BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3870521 · Received June 12, 2014

    Report

    Report Number
    3006630150-2014-01287
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    October 28, 2013
    Report Date
    April 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. CHARGE PROFILE REVEALED VARIOUS TIMES OF ERRATIC COUPLING/POOR ALIGNMENT OF THE CHARGER TO THE IPG. THE CHARGE CURRENT SOMETIMES REACHED THE MAXIMUM AND INDICATED GOOD ALIGNMENT, BUT THIS OPTIMAL ALIGNMENT WAS NOT CONSISTENT. THE REASON FOR THE ERRATIC COUPLING WAS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE WHICH WAS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITED NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD TO FREQUENTLY CHARGE THE IPG. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD TO FREQUENTLY CHARGE THE IPG. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD TO FREQUENTLY CHARGE THE IPG. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347932 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR