BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3024205 · Received March 27, 2013

    Report

    Report Number
    9614453-2013-00578
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3550-09, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED THE FOLLOWING: "THE INS HAD GOOD TELEMETRY AND OUTPUT. THE INS BATTERY WAS IN A LOW CONDITION. BASED ON THE PROGRAMMED PARAMETERS THAT THE INS HAD WHEN RECEIVED FOR ANALYSIS THE EXPECTED LIFE WAS 83 MONTHS. THE INS WAS IMPLANTED APPROXIMATELY 91 MONTHS. IT APPEARS THAT THE INS REACHED A NORMAL END-OF-LIFE CONDITION. THE INS CAN IS HERMETICALLY SEALED AND THERE IS NO VISIBLE EVIDENCE OF LEAKAGE. THE INTERNAL INS BATTERY IS ALSO HERMETICALLY SEALED AND IF THERE WAS ANY LEAKAGE OF THE BATTERY INSIDE THE INS CAN, IT WOULD DAMAGE THE HYBRID CIRCUIT AND THE INS WOULD MALFUNCTION. THIS INS IS FUNCTIONING NORMALLY INDICATING THAT THERE IS NO BATTERY LEAKAGE." FINAL ANALYSIS OF THE PLUG REVEALED ¿NO ANOMALY.¿

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) FELT THAT THE POCKET WAS CALCIFIED ANTERIOR TO THE BATTERY. IT WAS NOTED THAT THE TISSUE OVERLAYING THE BATTERY FELT "HARD LIKE PLASTIC" AND THE HCP WAS "ABLE TO SNAP THE TISSUE LIKE A PIECE OF PLASTIC COATING." IT WAS FURTHER NOTED THAT THE AREA WAS SLIGHTLY SMALLER THAN THE SIZE OF THE DEVICE. THE HCP REPORTEDLY COMMENTED THAT HE HAD NOT SEEN THIS BEFORE AND IT WAS "RATHER ABNORMAL." IT WAS FURTHER REPORTED THAT THE IMPLANTING SURGEON WAS CONCERNED THAT PERHAPS THE BATTERY "HAD LEAKED." IT WAS ALSO NOTED THE SAME HARD FIBROUS TISSUE WAS NOT POSTERIOR TO THE DEVICE POCKET. IT WAS ALSO NOTED THAT THERE WAS NO ABNORMAL FLUID FOUND IN THE POCKET. THIS ISSUE WAS REPORTEDLY DISCOVERED AT A ROUTINE SCHEDULED DEVICE REPLACEMENT DUE TO THE OLD DEVICE NEARING THE END OF SERVICE. IT WAS ALSO NOTED THAT THE PATIENT HAD NO COMPLAINTS REGARDING ISSUES WITH THE POCKET. IT WAS FURTHER REPORTED THAT THERE WAS NO INJURY OR ADVERSE EVENT AND THE CALCIFIED POCKET DID NOT CAUSE ANY SYMPTOMS OR COMPLICATION TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126252 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 742747

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR