BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3950034 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13347
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 30, 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 Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37092, LOT # 228530001, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3550-41, LOT # N172222, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EVERY SO OFTEN A PATIENT¿S THERAPY WENT TO ¿MAX POWER AND JUMPS FULL POWER,¿ ¿SHOCKED THE HECK OUT OF HIM AND THE BODY GOT STIFF.¿ A SHOCKING OR JOLTING SENSATION WAS REPORTED. THE PATIENT STATED THAT HE TRIED TO USE THE PATIENT PROGRAMMER TO TURN STIMULATION OFF BUT IT DIDN¿T GO OFF INSTANTLY SOMETIMES. IT WAS STATED THAT IT OCCURRED BOTH WHEN HE WAS ADJUSTING THE ¿PULSE¿ (PULSE WIDTH) BUT ALSO ON ITS OWN. IT WAS STATED THAT IT STARTED 3-4 MONTHS AGO AND THE PATIENT ¿FIGURED IT WAS A GLITCH OR SOMETHING.¿ IT WAS REPORTED THAT THE PATIENT ¿HAD A SLIP BUT NOTHING MAJOR AND THE PATIENT DID NOT REMEMBER WHEN.¿ THE PATIENT REPORTED THAT HE HAD MULTIPLE FALLS WITHIN THE LAST 6 MONTHS AND HAD A FEW FALLS BECAUSE HE HAD A LOT OF ¿ELECTRICAL PROBLEMS¿ IN THE BACK AND GOT ¿PINCHED BAD¿ AND THE ¿BODY REFLEX AND BODY GO DOWN.¿ IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SEEMED TO BE A LITTLE MORE ¿FLEXIBLE¿ THAN THE FIRST INS. IT WAS STATED THAT THE PATIENT¿S WIFE NOTICED IT ¿RECENTLY¿ AND THE PATIENT THOUGHT THE INS FELT ¿LOOSER¿ AND MOVED/SHIFTED IN HIS HAND. IT WAS STATED THAT DURING THE CALL THE INS MOVED ABOUT AN INCH IN HIS HAND BUT THE PATIENT DIDN¿T KNOW IF THAT WAS NORMAL AND DID NOT RECALL HOW IT FELT WHEN HE FIRST HAD IT IMPLANTED. THE PATIENT STATED HE WAS ¿WAITING TO SEE IF IT HAPPENED AGAIN¿. THE PATIENT STATED IT WAS ¿PRETTY INTENSE;¿ HE WAS ON LEVEL 3 AND ALL OF A SUDDEN IT WOULD GO TO MAX POWER IT COULD GO, MEANING VOLTAGE, AND IT DID IT WITH AND WITHOUT THE PATIENT PROGRAMMER. THE PATIENT EXPRESSED HE WAS CONCERNED THAT IF IT HAPPENED WHEN HE WAS DRIVING IT COULD BE SCARY AND STATED IT WAS PRETTY POWERFUL AND MADE HIS BODY LOCK UP AND ¿INTENSE.¿ THE PATIENT NOTED THAT HE HAD 2 PATIENT PROGRAMMERS AND SWITCHED TO THE OTHER DEVICE AND COULD NOT DUPLICATE THE ACTION. THE PATIENT REPORTED THAT HE WAS NOT GETTING THE FULL ¿AFFECT¿ OF THE THERAPY BUT HE KNEW IT WORKED BECAUSE OF HOW BAD NERVE PINCHING WAS AND HE GETS GOOD RELIEF, BUT HE SHOULD NOT HAVE AS MUCH PINCH AS HE DOES NOW. THE PATIENT REPORTED THAT HIS HEALTHCARE PROFESSIONAL (HCP) THOUGHT IT WAS ¿COMING FROM ANOTHER AREA¿ AND WAS TRYING TO TALK THE PATIENT INTO ANOTHER SURGERY, BUT THE PATIENT ¿DID NOT WHAT TO GET CUT AGAIN, HE WAS TIRED OF GETTING CUT.¿ THE PATIENT NOTED THAT IT ¿SCARED¿ HIM THE WAYS IT JUMPED WITHOUT THE PATIENT PROGRAMMER. THE PATIENT STATED THAT HE HAS USED THE PROGRAMMER TO TURN STIMULATION OFF; AND WHEN HE WAS ADJUSTING IT, IT JUMPED, AND THAT TRYING TO GET IT TURNED OFF WAS PRETTY INTENSE AND FIGHTING THE PAIN. THE PATIENT REPORTED IT MADE THE MUSCLE GO INTO A BIG SPASM BUT LOCKED UP AND WAS VERY INTENSE, LIKE PUTTING A FINGER IN A LIGHT SOCKET, AND THE BODY WENT STIFF. IT WAS STATED THAT THE PATIENT WOULD GIVE HIS MANUFACTURER¿S REPRESENTATIVE A CALL TO SEE IF SHE HAD OTHER IDEAS. IT WAS NOTED THAT THE PATIENT CALLED PATIENT SERVICES BEFORE AND WAS REDIRECTED TO THE HCP TO HAVE THE INS CHECKED. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE WAS NOT CU RRENTLY AWARE OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428621 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR