BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2694-2017 · Reported July 19, 2017

    Enforcement

    Recall Number
    Z-2694-2017
    Event ID
    77509
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St. Jude Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 19, 2017
    Initiation Date
    June 2, 2017
    Classification Date
    July 7, 2017
    Termination Date
    August 24, 2022
    Address
    6901 Preston Rd, Plano, TX, 75024-2508, United States

    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.

    Reason

    The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

    Code Info

    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

    Distribution

    US Nationwide Distribution

    Quantity

    54 units