BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3942606 · Received July 17, 2014

    Report

    Report Number
    3006630150-2014-01639
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1132 (SN- (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT VERIFIED. UPON RECEIVING, THE DEVICE BATTERY MEASURED 3.506 VOLTS, AND IT WAS CHARGED TO 3.987 VOLTS IN ONE CYCLE. THIS ATTESTED THAT THE DEVICE IS CAPABLE OF BEING FULLY CHARGED UNDER A PROPER CHARGING METHOD. REVIEW OF THE SYSTEM DATA LOG SHOWED A SUDDEN DROP IN BATTERY VOLTAGE FROM 3.816 TO 3.569 VOLTS AT ONE POINT. THE ROOT CAUSE OF THE SUDDEN BATTERY VOLTAGE DROP COULDN¿T BE DETERMINED AND DUPLICATED IN THE LAB. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418403 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR