BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3202583 · Received July 2, 2013

    Report

    Report Number
    3006630150-2013-01370
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE. DEVICE EVALUATION INDICATED THAT THE IPG PASSED ELECTRICAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED AS VARIOUS TEST LEADS WERE INSERTED IN BOTH PORTS. ALL IMPEDANCE READINGS WERE WITHIN NORMAL RANGE. HIGH IMPEDANCE READINGS COULD NOT BE DUPLICATED IN THE LAB. THE DEVICE EXHIBITED NORMAL IMPEDANCE CHARACTERISTICS. THE COMPLAINT OF THE PATIENT HAVING DIFFICULTY CHARGING HAS BEEN CONFIRMED. THE ANALOG INTEGRATED CIRCUIT (IC) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. THE ROOT CAUSE OF THE ANALOG IC DAMAGE WAS THE REPORTED USE OF MONOPOLAR ELECTROCAUTERY DURING A PRIOR UNRELATED PROCEDURE. THE 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 IC, REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2013 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS TO CHARGE THE IPG FREQUENTLY AND SOME OF THE LEAD CONTACTS WERE HAVING HIGH IMPEDANCES. THE PATIENT¿S CHARGING ISSUE STARTED AFTER A NON-DEVICE RELATED SURGERY WHEREIN CAUTERY WAS USED. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT WILL UNDERGO IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL (B)(6))

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS TO CHARGE THE IPG FREQUENTLY AND SOME OF THE LEAD CONTACTS WERE HAVING HIGH IMPEDANCES. THE PATIENT¿S CHARGING ISSUE STARTED AFTER A NON-DEVICE RELATED SURGERY WHEREIN CAUTERY WAS USED. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THE PATIENT WILL UNDERGO IPG REPLACEMENT. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL 9055940-001)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302477 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1