BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2921031 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00733
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 28, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 37092, LOT # 284950001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE 'STOPPED PROPER FUNCTION' AFTER THE CT MYELOGRAM. THE PATIENT WAS EVALUATED ON (B)(6) 2013 AND FELT THEIR 'DEVICE WAS STILL NOT FUNCTIONING PROPERLY.' IT WAS NOTED THAT STIMULATION WAS FELT MORE IN THE ABDOMEN THAN THE BACK. HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT OUTCOME WAS LISTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION, AN OVERSTIMULATION SENSATION AS WELL AS NEUROPATHY PAIN FOLLOWING A CT MYELOGRAM ABOUT 1.5 WEEKS PRIOR TO THE REPORT. AFTER THE CT MYELOGRAM, THE PATIENT FELT STIMULATION IN HER STOMACH WHEN SHE ADJUSTED STIMULATION THAT COVERED HER LEFT SIDE. THE REPORTER INDICATED THAT STIMULATION WAS OFF DURING THE SCAN. HOWEVER, THE AMPLITUDES WERE NOT TURNED DOWN TO ZERO AS THE GUIDELINES SPECIFIED. ABOUT A WEEK PRIOR TO THE REPORT, THE PATIENT UNDERWENT A PROCEDURE FOR THE MIGRAINE HEADACHES SHE HAD BEEN HAVING SINCE THE CT SCAN WAS DONE AS WELL AS AN EPIDURAL BLOOD PATCH. THE REPORTER INDICATED THAT THE PATIENT WAS INFORMED BY THE ANESTHESIOLOGIST THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) "WENT CRAZY." IT WAS SINCE THEN THAT THE PATIENT NOTICED THE INCREASE IN NEUROPATHY PAIN IN HER RIGHT LEG, BELOW THE KNEE AND DOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26543 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention