BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2221724 · Received August 24, 2011

    Report

    Report Number
    3006630150-2011-01344
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF DIFFICULTY CHARGING WAS CONFIRMED. AN OPEN CONNECTION FROM THE BATTERY NICKEL STRIP TO THE F2 FUSE CAUSED THE UNIT TO BE EFFECTIVELY TURNED 'OFF' SINCE NO CONNECTION TO THE BATTERY WAS PRESENT. THIS RESULTED IN THE PERCEIVED INABILITY TO CHARGE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING THE IPG. THE PHYSICIAN REPLACED THE PATIENT'S IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING THE IPG. THE PHYSICIAN REPLACED THE PATIENT'S IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention