BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2894273 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00078
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 39565-30, SERIAL#: (B)(4), PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 37743, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3708140, SERIAL#: (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708140, SERIAL#: (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS ALSO REPORTED THERE WAS NO STIMULATION SENSATION. THE PATIENT'S LEAD WAS IMPLANTED AT T10 VERTEBRAE BETWEEN THEIR SHOULDER BLADES. PATIENT REACHED FORWARD AND OVEREXTENDED THEIR ARM AND THEN HEARD A SNAP "LIKE A RUBBER BAND". PATIENT COULD FEEL "SOMETHING" NEAR T10 AND STILL HEARD "SNAPPING". IT WAS ALSO NOTED THE PATIENT WAS FEELING THIS SENSATION BEHIND THEIR KNEES WHEN THEY WALKED. IT WAS NOTED THIS STARTED RIGHT BEFORE THE REPORT. IT WAS ALSO NOTED THE PATIENT WAS NO LONGER FEELING STIMULATION. THE PATIENT HAD STIMULATION ON "LOW" BECAUSE IT WAS "BUGGING THEM". IT WAS NOTED THE PATIENT SAW A "CHARGE INS" WARNING SCREEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT ALSO DESCRIBED HER SHOCKING SENSATION "LIKE A ZIPLINE ACROSS HER BACK" AND WAS ALSO GETTING SHOCKS IN HER ABDOMEN. PATIENT REPORTED STIMULATION COVERAGE IS "OK" BUT SHE IS CONCERNED SHE SHEERED THE WIRES. IT WAS REPORTED TWO DAYS LATER THE PATIENT MET WITH THEIR DOCTOR AND MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. X-RAYS DID NOT SHOW MIGRATION OF THE LEADS. AFTER REPROGRAMMING, THE PATIENT IS REPORTEDLY GETTING ADEQUATE STIMULATION AGAIN, AND DOES NOT HAVE SHOCKING OR JOLTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THEY EXPERIENCED 'MANY' FALLS DUE TO SEIZURES AND THE LOSS OF FEELING IN THEIR LEG. IT WAS NOTED THAT THE PATIENT'S DOCTORS WERE AWARE OF THE FALLS AND HAVE TESTED THE IMPLANTABLE NEUROSTIMULATOR (INS) TO MAKE SURE EVERYTHING WAS FUNCTIONING CORRECTLY. THE PATIENT ALSO EXPERIENCED A 'ZAPPING' IN THE STOMACH AREA AND BEHIND BOTH KNEES ('LIKE RUBBER BANDS') AFTER THEY HYPEREXTENDED THEIR RIGHT ARM AND BENT FORWARD AT THE SAME TIME (WHICH CAUSED A PULLING SENSATION AROUND THE INS BATTERY). THE PATIENT ALSO EXPERIENCED DISCOMFORT, PAIN, AND IRRITATION ON THE SPINE DUE TO THE LEVEL OF STIMULATION FROM THE INS SINCE IMPLANTATION. IT WAS DESCRIBED AS A 'CONSTANT ACHE' WHICH THE INS CAN'T COVER (TARGET AREA MID BACK AND LEFT LEG). THE MANUFACTURER'S REPRESENTATIVE INTERROGATED THE INS (DATE UNKNOWN) AND NOTED THAT EVERYTHING WAS FINE. IN ADDITION, IT WAS REPORTED THAT THE PATIENT'S INS WAS IN AN OVERDISCHARGE CONDITION DUE TO PATIENT COMPLIANCE ISSUES. THE LAST SUCCESSFUL RECHARGE SESSION AND THE LAST TIME THE PATIENT FELT THE STIMULATION WAS 2 TO 6 MONTHS AGO. AFTER USE OF THE ANTENNA LOCATOR FEATURE ON THE RECHARGER, A POWER-ON-RESET (POR) WAS DISPLAYED WHICH THEN LED TO A NORMAL RECHARGE SCREEN. THE PATIENT WAS INSTRUCTED TO CHARGE FULLY THEN CONTACT THE MANUFACTURER'S REPRESENTATIVE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2410 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 00044 YR