BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW RECEIVER

    MDR report key: 2237076 · Received September 1, 2011

    Report

    Report Number
    1627487-2011-05102
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE, HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY, THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. THE RECEIVER FAILED BOTH MANUAL AND AUTO-TESTING FOR NO OUTPUT. THE ASIC'S AND OTHER INTERNAL COMPONENTS FAILED, CAUSING THE NO OUTPUT CONDITION. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2004. IT WAS REPORTED THAT THE PT'S STIMULATION WAS NOT AS STRONG AS IT USED TO BE. AN SJM REP WAS UNABLE TO MAKE THE STIMULATION STRONG ENOUGH. THE PT FELT THE STIMULATION IN THE RIGHT LOCATION. THE DOCTOR REPLACED THE RECEIVER WITH A RECHARGEABLE IPG. THE REPLACEMENT IPG RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW RECEIVER SPINAL CORD STIMULATION RECEIVER GZB ST JUDE MEDICAL - NEUROMODULATION 3416 24191A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SCS LEADS: MODEL 3186 (2)| IMPLANT: