BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5670375 · Received May 20, 2016

    Report

    Report Number
    3004209178-2016-10007
    Event Type
    Malfunction
    Date Received
    May 20, 2016
    Date of Event
    April 5, 2016
    Report Date
    May 20, 2016
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS REPORTED "A COUPLE OF WEEKS AGO" (LEAD 4 NOT WORKING) AND "PROBABLE 3 WEEKS AGO" (HITTING BATTERY PACK AGAINST HANDRAIL) IN (B)(6) 2016. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-45, LOT# V911223, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V821908, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# VA01TLD, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V800631, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THE "RIGHT LEAD" OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM DIDN'T SEEM TO BE WORKING AND THEIR BUTTOCK REGION WAS SORE. ADDITIONAL INFORMATION CLARIFIED THAT THE PATIENT WAS CARRYING DRYWALL UP A STAIRWAY (WALKING BACKWARDS) AND THEIR BUTTOCK HIT HE HANDRAIL AND PUSHED DOWN THE INS BATTERY PACK. THEY HAD PAIN IN THEIR RIGHT SIDE AND A LOSS OF THERAPY BUT THEY WERE NOT SURE IF THAT WAS CAUSED BY THE ABOVE EVENT. THE PATIENT REPORTED THAT THEY HAD 4 LEADS FOR MUSCLE SPASMS AND 3 OF THEM WERE ON THE LEFT SIDE AND 1 ON THE RIGHT SIDE. THEY STATED THAT THE LED ON THE RIGHT WAS "NOT WORKING." THE PATIENT MENTIONED THAT THEY HAD THE STIMULATION UP ALL THE WAY TO 10.5 AND "IT DOES NOT WORK." THEY DID NOT NOTICE WHEN IT HAD STOPPED WORKING BECAUSE IT WAS "USUALLY DOWN SO LOW." THE PATIENT NOTED THAT THEY HAD NOT SEEN THEIR DOCTOR SINCE IMPLANT OF THE DEVICE. THE INDICATIONS FOR USE FOR THE IMPLANTED DEVICE WERE NOTED AS NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. THERE WERE NO FURTHER DETAILS, TROUBLESHOOTING, INTERVENTIONS, OR AN OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324276 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR