BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3951069 · Received July 22, 2014

    Report

    Report Number
    3006630150-2014-01658
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS INDICATED THAT THE IPG PASSED THE INTERNAL AND VISUAL TESTS PERFORMED. THE DEVICE EXHIBITED THE SYMPTOMS OF ANALOG IC DAMAGE DUE TO HIGH-VOLTAGE TRANSIENT. IT WAS VERIFIED THAT DURING THE LEAD REVISION PROCEDURE ELECTROCAUTERY WAS USED ON THE PATIENT WHICH WAS THE ROOT CAUSE OF THE DEVICE DAMAGE. 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 DURING A REVISION PROCEDURE THE PHYSICIAN USED MONOPOLAR ELECTROCAUTERY WHILE THE IPG WAS OUTSIDE OF THE POCKET SITE. SINCE THEN THE IPG HAS NOT BEEN ABLE TO ESTABLISH COMMUNICATION WITH ANY DEVICES. TROUBLESHOOTING WAS PERFORMED BUT WAS NOT SUCCESSFUL. THE IPG WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A REVISION PROCEDURE THE PHYSICIAN USED MONOPOLAR ELECTROCAUTERY WHILE THE IPG WAS OUTSIDE OF THE POCKET SITE. SINCE THEN THE IPG HAS NOT BEEN ABLE TO ESTABLISH COMMUNICATION WITH ANY DEVICES. TROUBLESHOOTING WAS PERFORMED BUT WAS NOT SUCCESSFUL. THE IPG WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427648 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1