BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3754348 · Received April 16, 2014

    Report

    Report Number
    3004209178-2014-07359
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 25, 2014
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008 PRODUCT TYPE: LEAD. PRODUCT ID: 3776-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION . (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO STIMULATION SENSATION. IT WAS REPORTED THE PATIENT'S DEVICE HAD NOT BEEN WORKING. IT WAS NOTED THE PATIENT HAD A SPINAL CORD STIMULATION DEVICE IMPLANTED IN HER ARM FOR HER RADIAL NERVE. IT WAS LOGGED THAT THE PROBLEM THE PATIENT WAS HAVING WAS THAT SHE WAS NOT FEELING ANY STIMULATION. IT WAS NOTED THAT THERE WAS NOTHING GOING TO HER THUMB AND FOREFINGER. IT WAS REPORTED THE PATIENT WOULD PLACE HER PATIENT PROGRAMMER ON HER STOMACH WHERE THE DEVICE WAS IMPLANTED AND EVERYTHING WENT UP AND DOWN, BUT THE PATIENT FELT NO STIMULATION. IT WAS REPORTED THE PATIENT HAD VERIFIED THAT STIMULATION WAS ON AND HAD ATTEMPTED TO DECREASE AND INCREASE STIMULATION, BUT THE PATIENT STILL DID NOT FEEL ANY STIMULATION. IT WAS NOTED THAT ALL OF THIS HAD BEEN GOING ON FOR 3 DAYS. IT WAS LOGGED THE PATIENT HAD NOT HAD ANY RECENT FALLS OR TRAUMA NOR HAD SHE BEEN NEAR ANY "POWER THINGS". IT WAS LOGGED THE PATIENT MAY HAVE "SCREWED SOMETHING UP" WITH HER DEVICE BUT SHE DID NOT KNOW. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS HIGH IMPEDANCE OF >10,000 AND THERE WERE NO INTERVENTIONS TAKEN OR PLANNED AT THE TIME OF REPORT, BUT THE HEALTH CARE PROVIDER HAD BEEN INFORMED OF THE RESULTS. IT WAS LOGGED THE PATIENT WAS NOT USING THERAPY AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A PNS (PERIPHERAL NERVE STIMULATION) SYSTEM IN AND THEY WERE REPLACING THE LEAD. IT WAS NOTED THAT THE CALLER WANTED TO KNOW IF LEAD WAS PLACED TOWARD THE NERVE OR AWAY FROM THE NERVE FOR PNS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN "ON POINT 3987A". IT WAS STATED THAT THE IMPEDANCE CHECK OF THE LEAD WAS WITHIN NORMAL LIMITS. IT WAS STATED THAT THE BATTERY WAS REPLACED FROM A NON-RECHARGEABLE 37702 TO A RECHARGEABLE 37712. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S EXTENSIONS HAD TEST IMPEDANCES THAT WERE OUT OF NORMAL RANGE (>10000) IT WAS REPORTED THAT THE EXTENSION WAS REPLACED AND THE BATTERY WAS ELECTIVELY REPLACED. IT WAS STATED THAT INTRA-OP TESTING REVEALED IMPEDANCES WITHIN NORMAL LIMITS. IT WAS STATED THAT THE PLAN PER THE HEALTHCARE PROFESSIONAL (HCP) WAS THAT THE PATIENT'S BATTERY WOULD BE TURNED ON IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231923 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention