BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2830588 · Received November 13, 2012

    Report

    Report Number
    3006630150-2012-02084
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    June 27, 2012
    Report Date
    July 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF FREQUENT/DIFFICULTY CHARGING WAS CONFIRMED. THE RETURNED IPG PASSED ELECTRICAL, PHOTOGRAPHIC AND VISUAL INSPECTION TESTS PERFORMED. THE ANALOG IC (AIC-U1) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. THE AIC-U1 DAMAGE RESULTED IN THE RAPID BATTERY DEPLETION RATE OF THE IPG. MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC-U1, ((B)(4)). THE REPORTED USE OF ELECTROCAUTERY DURING A PREVIOUS SPINE SURGERY RESULTED IN THE ANALOG IC DAMAGE.

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE IPG 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S REMOTE CONTROL DISPLAYED ERROR CODE F7. THE PATIENT HAD A NON-DEVICE RELATED SURGERY AND SUBSEQUENTLY HAD DIFFICULTY CHARGING THE IPG AND HAD TO CHARGE FREQUENTLY. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THERE WILL BE NO FURTHER COURSE OF ACTION TAKEN REGARDING THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S REMOTE CONTROL DISPLAYED ERROR CODE F7. THE PATIENT HAD A NON-DEVICE RELATED SURGERY AND SUBSEQUENTLY HAD DIFFICULTY CHARGING THE IPG AND HAD TO CHARGE FREQUENTLY. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THERE WILL BE NO FURTHER COURSE OF ACTION TAKEN REGARDING THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S REMOTE CONTROL DISPLAYED ERROR CODE F7. THE PATIENT HAD A NON-DEVICE RELATED SURGERY AND SUBSEQUENTLY HAD DIFFICULTY CHARGING THE IPG AND HAD TO CHARGE FREQUENTLY. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THERE WILL BE NO FURTHER COURSE OF ACTION TAKEN REGARDING THE IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S REMOTE CONTROL DISPLAYED ERROR CODE F7. THE PATIENT HAD A NON-DEVICE RELATED SURGERY AND SUBSEQUENTLY HAD DIFFICULTY CHARGING THE IPG AND HAD TO CHARGE FREQUENTLY. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. THERE WILL BE NO FURTHER COURSE OF ACTION TAKEN REGARDING THE IPG.

    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