BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2071099 · Received April 27, 2011

    Report

    Report Number
    3006630150-2011-00617
    Event Type
    Injury
    Date Received
    April 27, 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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE ANALOG IC ((B)(4)) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. THE (B)(4) DAMAGE RESULTED IN THE RAPID BATTERY DEPLETION RATE OF THE IPG. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE (B)(4). CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN'S IMPLANT MANUAL (B)(4)). IT WAS REPORTED THAT PATIENT HAD A LUMBAR FUSION SURGERY BACK IN (B)(6) 2010 AND ELECTROCAUTERY WAS USED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING A CHARGE FOLLOWING A LUMBAR FUSION. AN BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IT WAS CONFIRMED THAT MONOPOLAR ELECTROCAUTERY WAS USED DURING THE LUMBAR FUSION. THE PATIENT'S IPG WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS NOT HOLDING A CHARGE FOLLOWING A LUMBAR FUSION. AN BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IT WAS CONFIRMED THAT MONOPOLAR ELECTROCAUTERY WAS USED DURING THE LUMBAR FUSION. THE PATIENT'S IPG WAS REPLACED AND THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention