BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RECEIVER KIT, 16-CHANNEL

    MDR report key: 4485028 · Received February 4, 2015

    Report

    Report Number
    1627487-2015-12056
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    November 28, 2014
    Report Date
    April 6, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REPORT FOR ¿INEFFECTIVE STIMULATION¿ WAS CONFIRMED. THE RENEW RECEIVER FAILED MANUAL TESTING FOR NO OUTPUT. THE ASIC¿S AND/OR OTHER INTERNAL COMPONENTS HAVE FAILED CAUSING THE NO OUTPUT CONDITION. THE RECEIVER WAS IMPLANTED FOR APPROXIMATELY 11 YEARS (3,931 DAYS). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER SHOULD BE K992946. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS UNABLE TO INCREASE STIMULATION WHICH WAS VERIFIED BY AN SJM REPRESENTATIVE. THE PATIENT HAS NOT USED THE SYSTEM IN OVER A YEAR. THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. THE PATIENT REPORTEDLY RECEIVES EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82430 RENEW RECEIVER KIT, 16-CHANNEL SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3416 26016A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other MODEL 3186(2), SSC LEAD