BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3831118 · Received May 23, 2014

    Report

    Report Number
    3006630150-2014-01163
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT PER PHYSICIAN¿S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO AN IPG REPLACEMENT PROCEDURE. IT IS INDICATED THAT THE DEVICE 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG, FREQUENT IPG CHARGING, AND DIFFICULTY COMMUNICATING IPG AFTER A PREVIOUS NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED. THE PATIENT WILL UNDERGO AN 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).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG, FREQUENT IPG CHARGING, AND DIFFICULTY COMMUNICATING IPG AFTER A PREVIOUS NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED. THE PATIENT WILL UNDERGO AN 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).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG, FREQUENT IPG CHARGING, AND DIFFICULTY COMMUNICATING IPG AFTER A PREVIOUS NON-DEVICE RELATED SURGERY WHEREIN AN ELECTROCAUTERY WAS USED. THE PATIENT WILL UNDERGO AN 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)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308613 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1