BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2880418 · Received December 19, 2012

    Report

    Report Number
    3004209178-2012-12067
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 27, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. IT WAS STATED THE INS WAS RECEIVED IN AN OVERDISCHARGED CONDITION. TELEMETRY WAS RESTORED AFTER ONE PHYSICIAN RECHARGE MODE. AFTER, THE INS FUNCTIONED PROPERLY. THE BATTERY HAD DEPLETED TO LOCK MODE ON (B)(6) 2012, ACCORDING TO THE TRACE REPORT FROM THE INS. IT WAS NOTED THAT FOUR RECHARGE SESSIONS OF BETWEEN 44 MINUTES AND ABOUT 4 HOURS WERE DONE WHILE THE INS WAS IMPLANTED; HOWEVER, NONE OF THE SESSIONS BROUGHT THE BATTERY OUT OF LOCK MODE. THIS WAS THE CASE BECAUSE THERE WERE 0 BARS OF COUPLING RECORDED BY THE INS 5-7 MINUTES INTO EACH RECHARGE SESSION. THE POOR COUPLING WAS ULTIMATELY THE CAUSE OF THE BATTERY NOT BEING CHARGED, AND EVENTUALLY BEING PUT INTO AN OVERDISCHARGED STATE. ANALYSIS OF THE PLUG (PRODUCT NUMBER: 3550-29) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO NOT BEING ABLE TO TURN THE DEVICE ON. THE REPORTER STATED THAT THE PATIENT WAS TRANSFERRED TO A DIFFERENT LOCATION AT WORK WITH INCREASED ELECTROMAGNETIC INTERFERENCE AND THE DEVICE SHUT OFF AND WOULD NOT RECHARGE. THE DEVICE WAS EXPLANTED ON (B)(6) 2012. THE MANUFACTURER REPRESENTATIVE SUSPECTED THAT COMPLIANCE MAY HAVE BEEN A FACTOR. THE DATE OF THE EVENT WAS UNKNOWN. IT WAS STATED THAT THE PATIENT HAD NO PROBLEMS WITH THE NEW IMPLANT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EXPLANT WAS DUE TO A 'DEAD' BATTERY. THERE WAS NO PATIENT INJURY. IT WAS STATED THAT THE PATIENT WAS DOING WELL. THE PATIENT WAS STILL AT THE SAME LOCATION AT WORK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S FIRST IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED DUE TO THE INABILITY TO CHARGE THE INS AND THE INS GETTING DEPROGRAMMED DUE TO STORMS. THE PATIENT WAS CHARGING EVERY THREE DAYS AND THEN THEY WERE NOT ABLE TO CHARGE. THE INABILITY TO CHARGE HAD DEVELOPED AFTER THEY HAD THE INS FOR A WHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention