BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3041432 · Received April 8, 2013

    Report

    Report Number
    6000032-2013-00082
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7425, SERIAL # (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3587A, LOT # L52050, IMPLANTED: (B)(6) 1998, PRODUCT TYPE LEAD; PRODUCT ID 7434-E, SERIAL # (B)(4), IMPLANTED: (B)(6)1998, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL # (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7496-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1993, PRODUCT TYPE EXTENSION; PRODUCT ID 3986, SERIAL # (B)(4), IMPLANTED: (B)(6) 1993, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED OVERSTIMULATION INTERMITTENT STIMULATION AND DEPLETED IMPLANTABLE NEUROSTIMULATORS (INS). IT WAS STATED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION, AND SHE HAD NOT USED THE DEVICE SINCE THE SECOND DEVICE WAS PUT IN. IT WAS ALSO STATED SHORTLY AFTER THE SECOND IMPLANT, "THE DEVICE FAILED AND THE PATIENT HAS NOT USED THE DEVICE OR THERAPY SINCE." IT WAS NOTED THE PATIENT WENT THROUGH IMPLANTED BATTERIES EVERY TWO OR THREE MONTHS BECAUSE SHE HAD THE AMPLITUDE HIGH IN ORDER TO STIMULATE FOR BOTH LEGS PAIN. THIS WAS WHEN THE PATIENT DECIDED TO HAVE THE SECOND INS IMPLANTED SO EACH LEG WAS CONTROLLED SEPARATELY. THE PATIENT STATED THE PHYSICIAN TOLD HER "THERE WAS NOT MUCH SPACE WHERE HE HAD TO PLACE THE ELECTRODE, AND THAT THE LEAD WAS SHOVED INTO THE SPACE AND THAT IT CAUSED ADHESIONS TO RIP." IT WAS THEN STATED "FOLLOWING, THE PATIENT WAS ON FIRE" AND THE HEALTHCARE PROVIDER (HCP) TRIED TO GET THE DEVICE TO WORK AFTER IMPLANT AND "IT WOULD NOT WORK." THE HCP TOLD HER THAT SHE WAS NOT A CANDIDATE FOR FURTHER BATTERIES ON THE LEFT SIDE BECAUSE SHE HAD "SO MANY." THE PATIENT WAS TOLD THAT THE RIGHT SIDE BATTERY WAS "USE D UP, BUT SHE DID NOT EVEN REALIZE IT WAS TURNED ON." IT WAS REPORTED THE HCP TESTED BOTH BATTERIES "MANY YEARS AGO" AND CONFIRMED THAT BOTH BATTERIES WERE "DEAD." THE PATIENT STATED SHE HAD PROBLEMS WITH HER ABDOMEN "AT ONE TIME" BUT HER HCP STATED IT WAS NOT THE INS BECAUSE THEY WERE BOTH "DEAD." THE HCP STATED HE PREFERRED NOT TO REMOVE THE BATTERIES. IT WAS ALSO REPORTED SHE WAS LEANING OVER THE COUNTER AT HER PARENT'S HOUSE IN (B)(6) 2012 AND IT FELT LIKE SHE "GOT BURNED REALLY BADLY", AND THAT SKIN CAME OFF "LIKE IT WAS A SMALL BURN." REPORTEDLY, THE SAME NIGHT AROUND 7/8 PM SHE WAS SLEEPING ON THE SOFA AND WHEN SHE WOKE UP AND THE DEVICE WAS ON "SO HIGH THAT SHE FELT BAD VIBRATING FROM THE BEND IN HER LEGS TO HER HEAD." THE PATIENT SAID "IT WAS AGONY; SHE DID NOT KNOW HOW THE DEVICE CAME ON BECAUSE THE DEVICE WAS TURNED OFF IN 1999." IT WAS STATED THE DEVICE THEN CONTINUED TO "COME ON AND OFF AND JOLT HER." IT WAS NOTED BY THE PATIENT THAT IN HER VEHICLE THE DEVICE WAS TURNED OFF. SHE SAID AT HER PARENT'S HOUSE THE DEVICE CONTINUED TO "GO ON AND OFF." THEN THE PATIENT WENT HOME AND IT CONTINUED TO "GO ON AND OFF." TWO WEEKS PRIOR TO REPORT, AT THE PATIENT'S HOME SHE WOKE UP AND THE DEVICE WAS ON AGAIN. THE PATIENT SAID THIS HAPPENED WHEN SHE WOULD SLEEP ON THE SOFA, AND WHEN SHE WOKE UP "THE DEVICE WENT OFF." REPORTEDLY, THE PATIENT ONLY FELT THE DEVICE "ON VIBRATING WHEN SHE SLEPT AND IT CAUSED HER CHEST, HEAD AND LEGS TO VIBRATE PAINFULLY." THE PATIENT SAID THAT A YEAR PRIOR TO REPORT SHE CONSIDERED HAVING HER BATTERIES REMOVED BUT THAT HER HCP WOULD NOT REMOVE THEM. THE PATIENT WAS REDIRECTED TO HER HCP AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142739 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1