BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4050239 · Received September 1, 2014

    Report

    Report Number
    3006630150-2014-01932
    Event Type
    Malfunction
    Date Received
    September 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME. IT IS INDICATED THAT THE DEVICE 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

    EXPIRATION DATE: NI.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT. DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANT. IT DEPLETED QUICKER THAN IT USED TO. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANT. IT DEPLETED QUICKER THAN IT USED TO. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANT. IT DEPLETED QUICKER THAN IT USED TO. A BSN REPRESENTATIVE ANALYZED THE IPG DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IPG REPLACEMENT HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531545 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR