BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1212630 · Received October 24, 2008

    Report

    Report Number
    2029203-2008-00857
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT OF THE PATIENT HAVING PROBLEMS LOCATING AND CHARGING HER IMPLANT WAS REPORTED. THE ORIGINAL IMPLANT WAS LOCATED IN THE PATIENT'S BACK HOWEVER, THE DOCTOR MOVED THE IPG TO THE ABDOMEN. AFTER THE REVISION THE PATIENT REPORTED HER DIFFICULTY CHARGING BEGAN. ADDITIONALLY, THE PATIENT REPORTED THAT THE POCKET IS BIG THAT THE IPG CAN BE FLIPPED. THE PATIENT HAS BEEN RE-EDUCATED ON PROPER CHARGING TECHNIQUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention