BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3873388 · Received June 13, 2014

    Report

    Report Number
    3006630150-2014-01346
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS CHARGING THE IPG FREQUENTLY. THE PATIENT HAD A PREVIOUS REVISION WHEREIN ELECTROCAUTERY WAS USED. 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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN WANTED TO UPGRADE THE PATIENT¿S IPG DUE TO THE AGE OF THE BATTERY. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DID WELL POST OPERATIVELY. NO MALFUNCTION WAS SUSPECTED. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. 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¿S IPG WAS FAILING AND WAS NOT HOLDING A CHARGE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS FAILING AND WAS NOT HOLDING A CHARGE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS FAILING AND WAS NOT HOLDING A CHARGE. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350131 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1