BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3012496 · Received March 20, 2013

    Report

    Report Number
    3006630150-2013-00453
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PLANNED REVISION WOULD NOT TAKE PLACE IN THE NEXT FEW MONTHS AS THE PATIENT IS CURRENTLY ON BLOOD THINNERS. THE PHYSICIAN SUSPECTED THAT THE DEFIBRILLATOR USED TO REVIVE THE PATIENT DURING THE NON-DEVICE RELATED MEDICAL PROCEDURE INTERFERED WITH THE IPG AND THE LEADS. THERE WILL BE NO FURTHER COURSE OF ACTION AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY LINKING WITH THE IPG. THE PHYSICIAN RECOMMENDED A BATTERY REPLACEMENT AND A POSSIBLE LEAD REPLACEMENT. THE PATIENT WAS ALSO PRESCRIBED WITH ADDITIONAL PAIN MEDICATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY LINKING WITH THE IPG. THE PHYSICIAN RECOMMENDED A BATTERY REPLACEMENT AND A POSSIBLE LEAD REPLACEMENT. THE PATIENT WAS ALSO PRESCRIBED WITH ADDITIONAL PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115788 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention