BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2040950 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02225
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MDT 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).

    Description of Event or Problem · 1

    THE NEXT DAY 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 PT WAS SENT HOME TO TRY 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, PT 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 PT HAD 2 ACTIVE STIMULATORS. ONE INS WAS WORKING FINE AND THE OTHER INS HAD NO TELEMETRY AND HAD NOT HAD TELEMETRY SINCE (B)(6) OR (B)(6) WHEN PT THOUGHT THEY LAST HAD STIMULATION WITH THAT INS AS WELL. THE PT ATTEMPTED AT THAT TIME TO USE THE PT PROGRAMMER TO INCREASE VOLTAGE AND RECEIVED THE TELEMETRY ERROR MESSAGE, AND WAS UNABLE TO CHARGE THE INS. SINCE THAT TIME THE PT 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 PMR WAS PERFORMED. DEVICE EXPLANT WAS BEING CONSIDERED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR LEAD: MODEL 3777, LOT# V038907023| EXTENSION: MODEL 37081, LOT# NJB054740V| LEAD: MODEL 3777, LOT# V296463039| LEAD: MODEL 3777, LOT# V038907025| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA129962N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB049523V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| MODEL 37712, LOT# NKF713370H| ACCESSORY: MODEL 37752, LOT# NKA129809N| PROGRAMMER: MODEL 37743, LOT# NKE128236N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V296463038| PROGRAMMER: MODEL 37743, LOT# NKE129725N