Events

Safety Alert for RELIANCE 4-FRONT

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Boston Scientific.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-05-22
  • Event Date Posted
    2015-05-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150522a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: boston scientific reliance 4-front medical device manufacturer, boston scientific, has issued a medical device safety alert concerning reliance 4-front. the affected devices are identified as follows:- model numbers: 1) 0682; 2) 0692 serial numbers: 1) 121478, 121502, 121485, 121503, 121488, 121504, 121489, 121505, 121490, 121506, 121491, 121507, 121494, 121509, 121495, 121510, 121497, 121511, 121501, 121514; 2) 121454, 121466, 121481, 121516, 121527, 121455, 121467, 121482, 121517, 121528, 121456, 121468, 121483, 121519, 121530, 121458, 121469, 121484, 121520, 121531, 121459, 121470, 121487, 121521, 121532, 121460, 121472, 121492, 121522, 121533, 121461, 121473, 121493, 121523, 121534, 121462, 121475, 121496, 121524, 121538, 121463, 121476, 121508, 121525, 121540, 121464, 121477, 121515, 121526, 121541, 121465, 121479 according to the manufacturer, one lead of a subset of seventy-two boston scientific reliance 4-fronttm single coil defibrillation leads distributed in europe and japan exhibited intermittent high pacing impedance and oversensing at implant. laboratory analysis determined that the terminal ring for the distal shock electrode was not fully connected to the conductor cable. further investigation determined that manufacturing equipment used to attach the terminal ring to the conductor cable was slightly offset from the intended position for a short period of time. the seventy-two leads were manufactured during this offset period, and may have a terminal ring that was not fully connected to the conductor cable. if the terminal ring is not securely connected to the conductor cable, potential clinical symptoms may include high or intermittently high pacing or shock lead impedance, noisy electrograms (egms) (particularly during pocket manipulation), or sensing anomalies that could affect either pacing pulses or shocks. a terminal ring that is not fully connected to the conductor cable could cause clinical symptoms during the replacement procedure. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 may 2015.

Device

RELIANCE 4-FRONT
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific RELIANCE 4-FRONT
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH