BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2870376 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02296
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS THEY WERE 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS REPLACED PER PHYSICIAN'S PREFERENCE. THE PATIENT HAD THE IPG FOR A LONG TIME. THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND WAS EXPERIENCING PAIN AND DISCOMFORT WHILE CHARGING THE IPG. THE PHYSICIAN CONFIRMED THAT THE IPG HAS SHIFTED MEDIAL . THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN THE OLD IPG WAS REPLACED WITH A NEW ONE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND WAS EXPERIENCING PAIN AND DISCOMFORT WHILE CHARGING THE IPG. THE PHYSICIAN CONFIRMED THAT THE IPG HAS SHIFTED MEDIAL. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE WHEREIN THE OLD IPG WAS REPLACED WITH A NEW ONE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention