BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3930417 · Received July 11, 2014

    Report

    Report Number
    3006630150-2014-01580
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD NO PROBLEMS WITH IPG TAKING A CHARGE. THE PATIENT FELT LIKE THE IPG WAS HEATING UP WHILE CHARGING. THE PATIENT¿S BIGGEST ISSUE WAS NOT WITH CHARGING, BUT WITH THE DEVICE NOT HELPING WITH HIS PAIN. THE PHYSICIAN DID NOT SUSPECT DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING ISSUES OVER THE IPG SITE AND HAD TROUBLE SLEEPING IF HE WAS LYING ON THE LEFT SIDE. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING ISSUES OVER THE IPG SITE AND HAD TROUBLE SLEEPING IF HE WAS LYING ON THE LEFT SIDE. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING ISSUES OVER THE IPG SITE AND HAD TROUBLE SLEEPING IF HE WAS LYING ON THE LEFT SIDE. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406156 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention