BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2251505 · Received September 16, 2011

    Report

    Report Number
    3006630150-2011-01368
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT WAS CONFIRMED. THE IPG WAS UNABLE TO MAINTAIN THE CHARGE DUE TO EXCESSIVE CURRENT LEAK. SLEEP CURRENT MEASURED 25.5 MA HIGHER THAN THE TYPICAL RANGE. ANALOG IC EXHIBITED A HOT SPOT. THE ROOT CAUSE OF THE ANALOG IC DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION AND DECIDED TO REPLACE THE IPG. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION AND DECIDED TO REPLACE THE IPG. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE REVISION PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention