BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3023707 · Received March 27, 2013

    Report

    Report Number
    3006630150-2013-00553
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    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

    UPDATE TO THE INITIAL MDR IN FIELDS: ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPLANTED AND IS REPORTEDLY DOING WELL.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED OPERATIONAL 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 INDICATES GOOD ALIGNMENT, BUT THIS OPTIMAL ALIGNMENT WAS NOT CONSISTENT. THE REASON FOR THE ERRATIC COUPLING IS UNKNOWN. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS. DURING ANALYSIS IT WAS DETERMINED THE BATTERY EXHIBITED IMPEDANCE OUT OF THE NORMAL RANGE. THIS WAS DUE TO CONFIRMED AUTOCLAVE USE AFTER THE DEVICE WAS EXPLANTED, AND IS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS TO FREQUENTLY CHARGE THEIR IMPLANT. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS TO FREQUENTLY CHARGE THEIR IMPLANT. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS TO FREQUENTLY CHARGE THEIR IMPLANT. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAS TO FREQUENTLY CHARGE THEIR IMPLANT. A BSN REPRESENTATIVE ANALYZED THE DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. AN IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126068 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1