Device Recall Infinity DBS IPG with MDT header

  • Model / Serial
    AAD257.1 AAD302.1 AAP362.1 AAP375.1 AAP385.1 ALX096.1 ALX257.1 ALX258.1 ALY268.1 ALY409.1 ALY435.1 ALY632.1 ALY640.1 ALY763.1 ALY780.1 ALY788.1 ALZ034.1 ALZ042.1 ANT267.1 ANT731.1 ZV3966.1 ZW0230.1 ZW0376.1 ZW0429.1 ZW0458.1 ZW0498.1 ZW0544.1 ZW0545.1 ZW0567.1 ZW0570.1 ZW0576.1 ZW0590.1 ZX5511.1 ZY9379.1 ZY9394.1 ZY9398.1 ZY9405.1 ZY9413.1 ZY9433.1 ZY9530.1
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    ALX120.1 ALX227.1 ALY287.1 ALY390.1 ALY471.1 ALY534.1 ALY560.1 ALY668.1 ALZ030.1 AMN762.1 AMN904.1 AMN990.1 AMP134.1 AMP169.1 AMP189.1 AMP246.1 AMS702.1 AMT135.1 AMT160.1 AMT357.1 ANG915.1 ANG951.1 ZA3446.1 ZA3511.1 ZB0872.1 ZB1144.1 ZB1181.1 ZB1188.1 ZB1190.1 ZB1200.1 ZB1213.1 ZB1218.1 ZB1225.1 ZB1422.1 ZB1463.1 ZB1507.1 ZK3289.1 ZS0594.1 ZS0699.1 ZS0772.1 ZW0246.1 ZW0268.1 ZW0273.1 ZW0283.1 ZW0364.1 ZW8776.1 ZW8796.1 ZW8863.1 ZW8879.1 ZW8887.1 ZW8904.1 ZW8965.1 ZW8972.1 ZX5593.1
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO || Product Usage: || The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
  • Manufacturer