BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1181783 · Received September 30, 2008

    Report

    Report Number
    2029203-2008-00558
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSOTN SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT OF PREMATURE BATTERY DEPLETION SHORTLY AFTER UNDERGOING A REVISION SURGERY WAS REPORTED. MONOPOLAR ELECTROCAUTERY WAS REPORTEDLY USED DURING THE REVISION SURGERY. THE COMPLAINT OF BATTERY DEPLETION WAS CONFIRMED AND THE DECISION WAS MADE TO REPLACE THE PATIENT'S PRECISION IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSOTN SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention