BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1091506 · Received August 1, 2008

    Report

    Report Number
    9614453-2008-04583
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES OF THE IMPLANTABLE PULSE GENERATOR. THE EPOXY BOND BETWEEN THE HYBRID CIRCUIT AND THE BATTERY TERMINAL WAS BROKEN. THE ELECTRICAL CONNECTIONS WERE INTACT; THERE WAS NO IMPACT TO DEVICE PERFORMANCE. THERE WERE NO ELECTRICAL ANOMALIES WITH THE HYBRID CIRCUIT THAT WOULD CAUSE A PREMATURE DEPLETION. THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS FOUND TO BE DEPLETED. THE DIFFERENCE BETWEEN THE ACTUAL BATTERY LIFE AND THE EXPECTED BATTERY LIFE MAY BE RELATED TO THE BREACHED DEPRESSION IN THE INSULATION ON THE EXTENSION TO THE #0 AND #1 CONDUCTORS.

    Description of Event or Problem · 1

    THE PATIENT FELT THE STIMULATION FROM THE DEEP BRAIN STIMULATOR WAS UNSTABLE. THE HCP SUSPECTED A SHORT IN THE EXTENSION OR EARLY BATTERY DEPLETION. PRIOR TO REPLACEMENT, THE HCP CHECKED IMPEDANCES BECAUSE HE SUSPECTED DAMAGE OF THE LEAD OR EXTENSION (RESULTS NOT REPORTED). THE PULSE GENERATOR AND THE EXTENSION WERE EXPLANTED AND REPLACED. INTRAOPERATIVELY THERE WAS NO EVIDENCE OF A SHORT IN THE EXTENSION. THE LEAD REMAINED IMPLANTED. THE HCP REPORTED THE PT OUTCOME AS 'RECOVERED'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC SWISS MANUFACTURING FACILITY 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention EXPLANTED| LEAD MODEL UNK| IMPLANTED| EXTENSION MODEL 7482| IMPLANTED| EXPLANTED