Safety Alert for IMPLANTABLE DEFIBRILLATOR GEM DR MODEL 7271 - ANVISA register 10339190053 and DEFIBRILLATOR IMPLANTAVEL 7223Cx - ANVISA registration 10339190013

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.

MEDTRONIC recommends: If the last monitoring has been in the last three months and records are available, check the battery voltage recorded and the charge time of the capacitor as below. · For all other cases, schedule a follow-up consultation as soon as possible and check the charge time of the capacitor as follows. · Schedule the exchange for any device with the following specification: Battery voltage of 5.16 V or less (NEW RECOMMENDATION) OR Charging time of 18 seconds or more. · If the battery voltage is greater than 5.16 Volts, check the charging time: If it is less than 18 seconds and greater than 14 seconds, set the Auto Capacitor Format Interval to one month. No additional reprogramming is required if the charge time is less than 14 seconds, or if the capacitor format is already programmed for one month. Continue to follow these patients at least every three months. These recommendations relate only to Micro Jewel 11 and Gem DR DCls identified by the serial numbers as attached list. No other Micro Jewell Model 7223Cx or GEM DR Model 7271 has been affected. Globally there were thirty (30) Micro Jewel 11 devices with capacitors that obtained unexpected circuit load performance at near-ERI battery voltages. Six (6) of these occurred during cardiac arrhythmias, resulting in undesired therapy. Although all reports with field action with the dates of the Micro Jewel 11 involved, it is possible that some DR GEM devices with suspected capacitors may exhibit similar behavior. So this recommendation applies to both Micro Jewel 11 (-1386 units globally) and GEM DR (-435 globally active) with suspect capacitors. These devices were deployed in 1997 and 1998.