BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 5540308 · Received March 31, 2016

    Report

    Report Number
    3006630150-2016-00732
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 4, 2016
    Report Date
    March 4, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED LEAD WAS NOT RETURNED TO BSN. IT IS INDICATED THAT THE LEAD WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SC-1132 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS CONFIRMED. THE PORT C WAS BLOCKED BY A FOREIGN MATTER AT THE INNER FIRST CONTACT. THE FOREIGN MATTER WAS A SEPARATED LEAD TIP. AS YELLOWISH DISCOLORATION, WHETHER DUE TO AGING, IT WAS MOST LIKELY INTRODUCED DURING THE REVISION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8116-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ON PORT C OF THE IPG. IT WAS NOTED THAT THE HIGH IMPEDANCE WAS PROBABLY CAUSED BY THE PATIENT¿S PREVIOUS REVISION (MFR REPORT #: 3006630150-2015-03370) WHEREIN ELECTROCAUTERY WAS USED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. THE PHYSICIAN BELIEVED THAT THE IPG WAS DAMAGED, AND DEVICE MALFUNCTION WAS ALSO SUSPECTED WITH THE LEAD SINCE THE TAIL WAS DAMAGED BECAUSE OF THE PREVIOUS REVISION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. 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).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ON PORT C OF THE IPG. IT WAS NOTED THAT THE HIGH IMPEDANCE WAS PROBABLY CAUSED BY THE PATIENT'S PREVIOUS REVISION (MFR REPORT #: 3006630150-2015-03370) WHEREIN ELECTROCAUTERY WAS USED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. THE PHYSICIAN BELIEVED THAT THE IPG WAS DAMAGED, AND DEVICE MALFUNCTION WAS ALSO SUSPECTED WITH THE LEAD SINCE THE TAIL WAS DAMAGED BECAUSE OF THE PREVIOUS REVISION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. 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
    192955 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1