BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1963865 · Received December 22, 2010

    Report

    Report Number
    3006630150-2010-02189
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT AND PRODUCT PROBLEM ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS REPLACED AND THE PATIENT WAS DOING WELL. THE RETURNED PRODUCT ANALYSIS CONFIRMED THE COMPLAINT OF DIFFICULTY CHARGING. THE EXPLANTED IPG PASSED VISUAL, PERFORMANCE, AN ELECTRICAL AND PHOTOGRAPHIC TEST PERFORMED. ADDITIONAL TESTING REVEALED THE ANALOG INTEGRATED CIRCUIT (AIC) DAMAGE, WHICH RESULTED IN THE RAPID BATTERY DEPLETION. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC. THE USE OF ELECTROCAUTERY DURING THE SURGERY PRIOR EXPLANT PROCEDURE RESULTED IN THE REPORTED COMPLAINT. CURRENT COMPANY LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HIS IPG. SEVERAL ATTEMPTS AT TROUBLESHOOTING WERE UNSUCCESSFUL. ANALYSIS OF THE PATIENT'S DATABASE REVEALED EVIDENCE OF PREMATURE BATTERY DEPLETION STARTING AROUND (B)(6) 2010. THIS WAS A TYPICAL FAILURE MODE FOLLOWING MONOPOLAR ELECTROCAUTERY DAMAGE. REPLACEMENT OF THE IPG HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS HAVING DIFFICULTY CHARGING HIS IPG. SEVERAL ATTEMPTS AT TROUBLESHOOTING WERE UNSUCCESSFUL. ANALYSIS OF THE PATIENT'S DATABASE REVEALED EVIDENCE FO PREMATURE BATTERY DEPLETION STARTING AROUND (B)(6) 2010. THIS WAS A TYPICAL FAILURE MODE FOLLOWING MONOPOLAR ELECTROCAUTERY DAMAGE. REPLACEMENT OF THE IPG HAS BEEN RECOMMENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention