BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2072160 · Received April 28, 2011

    Report

    Report Number
    3006630150-2011-00618
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT OF THE PREMATURE BATTERY DEPLETION OF IPG HAS BEEN CONFIRMED. THE ANALOG IC (AIC-U1) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. THE AIC-U1 DAMAGE RESULTED IN THE RAPID BATTERY DEPLETION RATE OF THE IPG. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL AND CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (REFER TO PHYSICIAN'S IMPLANT MANUAL (B)(4)).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REVISION DUE TO CHARGING DIFFICULTIES. A DATABASE ANALYSIS CONFIRMED PREMATURE BATTERY DEPLETION. THE PHYSICIAN REPLACED HE IPG AND THE PATIENT WAS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REVISION DUE TO CHARGING DIFFICULTIES. A DATABASE ANALYSIS CONFIRMED PREMATURE BATTERY DEPLETION. THE PHYSICIAN REPLACED HE IPG AND THE PATIENT WAS REPORTEDLY DOING FINE.

    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 45 YR Required Intervention