BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1870236 · Received October 11, 2010

    Report

    Report Number
    3006630150-2010-01713
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS DONE ON THE EXPLANTED IPG REVEALED THAT THE ANALOG IC HAS BEEN DAMAGED BY ELECTROCAUTERY. 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 9055940-001 REV. AB).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DIFFICULTY CHARGING. AN X-RAY WAS TAKEN AND CONFIRMED THAT THE IPG WAS SLIGHTLY ROTATED. RE-ALIGNING THE CHARGER WITH THE IPG DID NOT RESOLVE THE ISSUE. THE PHYSICIAN REPLACED THE PATIENT'S IPG AND THE PATIENT IS NOW ABLE TO FEEL STIMULATION.

    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 UNK Unknown Required Intervention