BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4100233 · Received September 18, 2014

    Report

    Report Number
    3006630150-2014-02133
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS REPORTEDLY DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578282 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention