BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3130458 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08193
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 6, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT'S DEVICE WOULDN'T TAKE A CHARGE PRIOR TO THE INCIDENT. IT WAS REPORTED THAT AN OVER DISCHARGE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SUSPECTED. THE LAST SUCCESSFUL RECHARGE SESSION WAS "OVER 12 MONTHS AGO". THE PATIENT HAD AN APPOINTMENT WITH HER DOCTOR SCHEDULED FOR (B)(6) 2013. IT WAS REPORTED THAT THERE WAS TELEMETRY ISSUES AND AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. A PHYSICIAN MODE RECHARGE (PMR) HAD BEEN BEING PERFORMED SINCE 7:30 AM ON THE DAY OF THIS REPORT. 4 PMR'S HAD BEEN DONE AND THEY WERE NOT ABLE TO GET THE NORMAL CHARGING SCREEN. THE PATIENT HAD DONE PMR THE ENTIRE DAY. PATIENT HAD NOT CHARGED IN GREATER THAN 2 YEARS. THERE WAS A POWER ON RESET (POR) CONDITION. IT WAS NOTED THAT THE PATIENT HAD HIP SURGERY AND SEVERAL OTHER HEALTH RELATED ISSUES. IT WAS NOTED THAT THE PATIENT HAD TRIED MULTIPLE TRIPLE CHARGES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN OVERDISCHARGE WAS CONFIRMED. IT WAS NOTED THAT THIS HAPPENED DUE TO LACK OF RECHARGING WHILE RECOVERING FROM OTHER SURGERIES. THE PATIENT HAD ATTEMPTED TO TRICKLE CHARGE MULTIPLE TIMES FOR 5 OR MORE HOURS WITHOUT SUCCESS. THE PATIENT HAD BECOME TIRED OF THE PROCESS AND WAS GOING TO TRY AT HOME AGAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S STIMULATION HAD "STOPPED" BACK IN 2010. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ORIGINALLY IMPLANTED TO COVER THE PATIENT'S BACK PAIN FROM A PRIOR BACK SURGERY. IT WAS STATED THAT THE PATIENT'S SPINE MOVED AFTER SURGERY AND "THEY SAY IT WAS ON THE NERVES". IT WAS NOT CLEAR WHAT THAT MEANT. THE PATIENT'S BACK SURGERY WAS A LAMINECTOMY AND REMOVAL OF 5 DISKS IN 2007. THAT WAS THE REASON FOR THE STIMULATION SYSTEM. IT WAS NOTED THAT THE STIMULATION WAS WORKING"FOR A LITTLE WHILE" AND THEN THE PATIENT STARTED HAVING PAIN IN HER HIP. IT WAS STATED THAT THE PAIN STARTED COMING FROM BOTH OF HER HIPS AND SHE HAD TO HAVE THEM BOTH REPLACED. THE PATIENT HAD TO HAVE A HIP REPLACEMENT IN 2010 OR 2011, THE REPORTER DID NOT REMEMBER, AND IT GOT INFECTED. IT WAS REPORTED THAT THE SURGEON "HAD TO GO IN 3 TIMES TO REPLACE IT AND ALSO CHECK IF THE (B)(6) INFECTION RESPONDED TO MEDICATION". THAT'S WHEN THE INS HAD STOPPED. IT WAS STATED THAT THE PATIENT WAS IN THE HOSPITAL FOR 3 MONTHS WITH THE HIP SURGERY. IT WAS ALSO NOTED THAT THE PATIENT HAD CONGESTIVE HEART FAILURE AND CAUGHT PNEUMONIA. THERE WAS NO INDICATION THAT THIS WAS CAUSED BY THE DEVICE. IT WAS STATED THAT THE PATIENT WAS UNABLE TO WALK WITHOUT A WALKER OR CRUTCHES, BUT THE PATIENT WAS NOT ABLE TO WALK BEFORE THE HIP SURGERY. IT WAS STATED THAT THE PATIENT GOT DEPRESSED FROM BEING SICK ALL OF THE TIME. IT WAS STATED THAT THE PATIENT WENT TO THE HOSPITAL IN (B)(6) 2013 FOR CONGESTIVE HEART FAILURE. THE DOCTOR GAVE HER TWO "BLOCK SHOTS" FOR THE PAIN. IT WAS REPORTED THAT THE PATIENT WAS IN "SO MUCH PAIN ON HER LEFT SIDE SHE WOULD JUST SCREAM". THE PATIENT'S FIRST "INJECTION" WAS IN (B)(6) 2013 AND SHE HAD ANOTHER ONE ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT HAD BEEN IN THE HOSPITAL 3 TIMES THIS YEAR FOR "CONGESTIVE HEART FAILURE, PNEUMONIA, WHATEVER". THERE WAS NO INDICATION OR ALLEGATION THAT THE INS HAD CAUSED OR CONTRIBUTED TO THIS. THE PATIENT WAS GOING TO GO BACK TO THE DOCTOR ON (B)(6) 2013 FOR HER "THIRD INJECTION". IT WAS STATED THAT THE PATIENT HAD NOT RECHARGED HER DEVICE IN OVER 12 MONTHS. AN INS OVER DISCHARGE WAS SUSPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230947 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1