BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2894642 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00085
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NECK SURGERY ON (B)(6) 2012 AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERFERING WITH THE ELECTROCARDIOGRAM (EKG) SO IT WAS TURNED OFF THROUGH-OUT THE SURGERY. EVER SINCE THE SURGERY, THE REPORTER WAS HAVING ISSUES WITH COUPLING AND/OR COMMUNICATION, AND HAD NOT BEEN ABLE TO GET PAST 2 COUPLING BARS. THE ANTENNA LOCATOR (AL) FEATURE WAS USED AND THE ANTENNA DIAL WAS ALSO ADJUSTED BUT BOTH ATTEMPTS AT TROUBLESHOOTING DID NOT MITIGATE THE PROBLEM, AND 0 COUPLING BARS WERE OBTAINED. THE REPORTER ALSO INDICATED THAT THERE WAS DRAINAGE OF A "REDDISH, TINGED SOLUTION" AT THE PATIENT'S SPINAL INCISION SITE AND IT "SOAKED THE BED". THIS HAPPENED AFTER THE NECK SURGERY AND WENT ON FOR 5 DAYS. THE PATIENT'S HEALTHCARE PROVIDERS (HCPS) ASSESSED THE SITUATION AND THE PATIENT WAS PUT IN ISOLATION BUT NO INFECTION WAS FOUND. THE REPORTER STATED THAT THE PATIENT WAS EXPERIENCING LOSS OF EFFICACY BECAUSE THE INS WAS DEPLETED AND SHE WASN'T GETTING THERAPY. THE PATIENT WAS NOTED TO BE IN REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3006 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1