BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2341058 · Received November 17, 2011

    Report

    Report Number
    3004209178-2011-09236
    Event Type
    Injury
    Date Received
    November 17, 2011
    Report Date
    November 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 389045 LOT# J0527037V IMPLANTED: (B)(6), 2005 EXPLANTED: (B)(6), 2011 LEAD MODEL 389045 LOT# J0527037V IMPLANTED: (B)(6), 2005 EXPLANTED: (B)(6), 2011 EXTENSION MODEL 748910 SERIAL# (B)(4) IMPLANTED: (B)(6), 2005 EXPLANTED: (B)(6), 2011 EXTENSION MODEL 748910 SERIAL# (B)(4) IMPLANTED: (B)(6), 2005 EXPLANTED: (B)(6), 2011 PROGRAMMER MODEL 7435 SERIAL# (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    RESULTS: ANALYSIS OF IPG MODEL 7427V SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. FUNCTIONAL TESTING SHOWED A FAILED, LOW/END-OF- LIFE BATTERY (NORMAL BATTERY DEPLETION) . THERE WAS A GOOD STABLE OUTPUT AT ALL ELECTRODE PAIRS IN THE INS TO EXTENSION. VISUALLY THERE WAS FOREIGN MATERIAL IN THE CONNECTOR PORT. ANALYSIS OF EXTENSION MODEL 748910 SERIAL # (B)(4) SHOWED NO ANOMALIES. THE PROXIMAL END OF THE EXTENSION WAS NOT VISUALLY EXAMINED BUT THE REST OF THE EXTENSION WAS OKAY. THE FUNCTIONAL SYSTEM TEST SHOWED GOOD STABLE OUTPUT FROM INS TO THRU THE EXTENSION AT ALL ELECTRODE PAIRS. ANALYSIS OF LEAD MODEL 389045 LOT# J0527037V SHOWED NO SIGNIFICANT ANOMALIES. THE LEAD WAS VISUALLY OK IN ALL ASPECTS EXCEPT FOR THAT THE INSULATION WAS CUT AND WRINKLED. THERE WAS COSMETIC ESC ON THE OUTER INSULATION. FUNCTIONAL TESTING SHOWED NO SHORTS BETWEEN CIRCUITS WITH ACCEPTABLE CONTINUITY. ANALYSIS OF LEAD MODEL 389045 LOT# J0527037V SHOWED NO SIGNIFICANT ANOMALIES. THE LEAD WAS VISUALLY OK IN ALL ASPECTS EXCEPT FOR THAT THE INSULATION WAS CUT AND WRINKLED. THERE WAS COSMETIC ESC ON THE OUTER INSULATION. FUNCTIONAL TESTING SHOWED NO SHORTS BETWEEN CIRCUITS WITH ACCEPTABLE CONTINUITY. ANALYSIS OF EXTENSION MODEL 748910 SERIAL# (B)(4) SHOWED NO ANOMALIES. THE EXTENSION WAS VISUALLY AND FUNCTIONALLY OKAY. THERE WAS A GOOD STABLE OUTPUT FROM INS TO EXTENSION IN ALL ELECTRODE PAIRS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION SENSATION. IT WAS LIKELY DUE TO IMPLANTABLE NEUROSTIMULATOR (INS) END-OF-LIFE. A REPLACEMENT SURGERY WAS SCHEDULED. IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO THE INS SITTING UNCOMFORTABLY IN THE POCKET. DURING THE SURGERY IT APPEARED THE LEAD WAS FRACTURED, AND HIGH IMPEDANCES WERE NOTED. THE ENTIRE SYSTEM WAS REPLACED. IT WAS NOTED THAT THE BATTERY DEPLETION WAS NORMAL. THERE WAS NO PATIENT INJURY, AND IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention