BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3820851 · Received May 20, 2014

    Report

    Report Number
    9614453-2014-01042
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 29, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND ¿THE INS HAD NO TELEMETRY WHEN IT WAS RECEIVED FOR ANALYSIS. DESTRUCTIVE ANALYSIS OF THE INS WAS PERFORMED. NO VISUAL OR ELECTRICAL ANOMALIES WERE FOUND WITH THE HYBRID CIRCUIT. THE INS BATTERY WAS FOUND TO BE DEPLETED. DESTRUCTIVE ANALYSIS OF THE BATTERY DID NOT REVEAL ANY INTERNAL ANOMALIES THAT WOULD HAVE CAUSED PREMATURE BATTERY DEPLETION. NO PARAMETER HISTORY WAS AVAILABLE SO THE EXPECTED LIFE COULD NOT BE DETERMINED. BASED ON THE ANALYSIS OF THE INS, THIS DEVICE REACHED A NORMAL END-OF-LIFE CONDITION. IT WAS ALSO OBSERVED THAT THERE WAS A SIGNIFICANT AMOUNT OF FOREIGN MATERIAL IN THE #0-3 CONNECTOR PORTS CONSISTENT WITH BODY FLUIDS; HOWEVER, THERE WERE NO ISSUES WITH THE GROMMETS OR SEALING RINGS. WHEN OR HOW THE FOREIGN MATERIAL ENTERED THE CONNECTOR PORT COULD NOT BE DETERMINED.¿

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETED PREMATURELY (¿SUSPECTED EARLY INS BATTERY DEPLETION¿). IT WAS NOTED THAT THE DURATION OF THE PREVIOUS INS WAS 4 YEARS AND THE PARAMETERS WERE THE SAME. THE INS WAS CONNECTED TO A QUAD TYPE OF LEAD COMPONENT, ¿NEVER REPLACED¿, AND ALWAYS SHOWED NORMAL IMPEDANCES (600 OHMS). THE INS BATTERY WAS REPLACED IN END-ON-SERVICE (EOS) STATE SO NO PROGRAMMING PRINT OUTS WERE AVAILABLE. THE INS BATTERY WAS REPLACED. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS AT THE TIME OF REPORT WAS ¿ALIVE ¿ NO INJURY¿. FOLLOW UP INFORMATION RECEIVED ON THE SAME DATE REPORTED THAT THE PATIENT HAD SYMPTOMS OF BACK TO BASELINE DUE TO THE LOSS OF STIMULATION. AFTER THE INS WAS REPLACED THEY WERE FINE. THE REPORTED SETTINGS OF THE NEW INS WERE: 2.8 VOLTS, 180 MICROSEC, 80 HZ, 2 POSITIVE ELECTRODES, 1 NEGATIVE ELECTRODE ON CONTINUOUS MODE. THE PATIENT NOTED THAT THIS STIMULATION WAS FELT THE SAME WITH THE REPLACED INS. FURTHER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 REPORTED THAT PATIENT DID HAVE A PROGRAMMER AND HAD THE UPPER LIMITS OF +/- 3 VOLTS. IT WAS ALSO REPORTED THAT THE EOS STATUS WAS REPORTED BY THE PHYSICIAN AND, ACCORDING TO THEM, NO OTHER ISSUE COULD HAVE CAUSED THE NO TELEMETRY CONDITION. FOLLOWING THE REPLACEMENT OF THE INS THE PATIENT WAS REPORTED AS RECEIVING EFFECTIVE THERAPY AND WAS DOING WELL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE INS HAD ¿NO TELEMETRY¿ WHEN RECEIVED BY THE MANUFACTURER NINE DAYS PRIOR TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299474 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention