BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4243530 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21321
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A290, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED IN (B)(6) 2014 BECAUSE IT MADE HER LEGS VERY WEAK AND SHE COULDN¿T WALK. THE PATIENT HAD PAIN AND CONSTANT BURNING AT THE INS SITE. THE STIMULATION VIBRATED IN HER STOMACH SO BAD THAT SHE FELT SICK ALL OF THE TIME. THE PATIENT WAS STILL FEELING A FALSE SENSE OF STIMULATION AND HER KNEES FELT LIKE THEY HAD ARTHRITIS IN THEM AT THE TIME OF THE REPORT. THE PATIENT HAD THE SYMPTOMS SINCE IMPLANT AND THEY GOT PROGRESSIVELY WORSE OVER TIME. THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THERE WERE NO REPORTS PER THE HEALTHCARE PROVIDER (HCP). THE PATIENT WAS SEEN (B)(6) 2013 AND REPORTED 100% RELIEF OF PAIN.¿ ON (B)(6) 2014, NOW HAD REVERSAL OF VASOMOTOR CHANGES FROM CRPS¿. THE HCP WAS NOT NOTIFIED OF ANY PROBLEMS AND THE PATIENT NEVER FOLLOWED UP. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND UNKNOWN IF DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD TROUBLE WALKING AND FELT STIMULATION IN CHEST/STOMACH. THE PATIENT HAD A CONSTANT FEVER UNTIL THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726843 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention