BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2101682 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03426
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS UNCLEAR WHICH STIMULATOR WAS HAVING PROBLEMS, SO A REPORT HAS BEEN FILED ON BOTH. SEE MFR REPORT # 3004209178201102225 FOR THE OTHER REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE CONTINUED TO BE COMMUNICATION ISSUES WITH THE RECHARGER. FIVE PHYSICIAN MODE RECHARGES (PMR) WERE ATTEMPTED, AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS STILL NOT RESPONDING. THE PATIENT WAS SENT HOME TO TRY TO SOME MORE PMRS. THE FOLLOWING DAY A PROBLEM WITH THE INS WAS SUSPECTED. THERE WERE CONTINUED TELEMETRY ISSUES. THE INS WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER, AND RECHARGER. A 582 ERROR CODE WAS NOTED IN THE HIDDEN CODES. TNI CODES WERE NOTED AS 582, 582, 582, 582, 601, 601, 0, 0, 0, 0. IT WAS NOTED THAT THE PATIENT HAD 2 ACTIVE STIMULATOR'S. ONE INS WAS WORKING FINE AND THE OTHER INS HAD NO TELEMETRY AND HAD NOT HAD TELEMETRY SINCE MARCH 6 OR 7 WHEN PATIENT THOUGHT THEY LAST HAD STIMULATION WITH THAT INS AS WELL. THE PATIENT ATTEMPTED AT THAT TIME TO USE THE PATIENT PROGRAMMER TO INCREASE VOLTAGE AND RECEIVED THE TELEMETRY ERROR MESSAGE, AND WAS UNABLE TO CHARGE THE INS. SINCE THAT TIME THE PATIENT HAD NOT BEEN ABLE TO CHARGE NORMALLY, AND DID NOT SEE A POR MESSAGE ON THE RECHARGER DURING THIS TIME. AN ANTENNA LOCATE WAS ATTEMPTED AFTER THE PRM WAS PERFORMED. DEVICE EXPLANT WAS BEING CONSIDERED. INFORMATION RECEIVED LATER CLARIFIED THAT THE PATIENT HAD A TOTAL OF 8 UNSUCCESSFUL "PORS". THE ONLY PATIENT SYMPTOM REPORTED WAS NO STIMULATION SENSATION. THE PATIENT VISITED WITH THEIR PHYSICIAN WHERE ANOTHER RECHARGE SESSION WAS ATTEMPTED. THE RECHARGE SESSION WAS SUCCESSFUL AND EVERYTHING WAS REPORTED AS "BACK TO NORMAL" WHERE THE PATIENT WAS ABLE TO RECHARGE AND GET STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37713,| ACCESSORY: MODEL 37752, LOT# NKA129962N| PROGRAMMER: MODEL 37743, LOT# NKE129725N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB049523V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V038907023| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V296463038| EXPLANTED:| LOT # NJK713068H| IMPLANTED:| LEAD: MODEL 3777, LOT# V038907025| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA129809N| LEAD: MODEL 3777, LOT# V296463039| EXTENSION: MODEL 37081, LOT# NJB054740V| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE128236N