BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 1022197 · Received March 26, 2008

    Report

    Report Number
    2029203-2008-00165
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE EXPLANTED LEAD WAS COMPLETED AND NO ANOMALIES WERE NOTED. THE IPG PASSED VISUAL AND PHOTOGRAPHIC IMAGE INSPECTION AS WELL AS MECHANICAL TESTS PERFORMED. THE DEVICE COULD NOT BE CHARGED; HOWEVER, IT REGAINED FUNCTIONALITY WHEN IT WAS POWERED UP WITH AN EXTERNAL POWER SUPPLY. THE IPG PASSED ONE OF THE ELECTRICAL TESTS PERFORMED. THE IPG EXHIBITED DAMAGE TO THE ANALOG INTEGRATED CIRCUIT WHICH CAUSED THE REPORTED FAILURE. THE EXACT CAUSE OF THE DAMAGE TO THE ANALOG IC COULD NOT BE DETERMINED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED CHARGING ISSUES BETWEEN THE IMPLANT AND EXTERNAL EQUIPMENT. DURING A LEAD REVISION, THE DECISION WAS MADE TO REPLACE THE PATIENT'S IMPLANT DUE TO THE PREVIOUS CHARGING ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED| SC-8116-70