BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2221050 · Received August 23, 2011

    Report

    Report Number
    3006630150-2011-01291
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT WAS CONFIRMED. THE BATTERY DEPLETION RATE CHANGED AFTER THE IMPLANT. THE DEVICE EXHIBITED EXCESSIVE CURRENT LEAKAGE. THE TIMING OF THE ANOMALY SUGGESTS THAT THE IPG MAY HAVE BEEN EXPOSED TO ELECTROCAUTERY OR SIMILAR TOOLS DURING THE IMPLANT PROCEDURE. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL AND CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY ((B)(6)).

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THE PHYSICIAN IMPLANTED PATIENT WITH A NEW IPG. THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THE PHYSICIAN IMPLANTED PATIENT WITH A NEW IPG. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention