BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2437074 · Received February 2, 2012

    Report

    Report Number
    3004209178-2012-00738
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Report Date
    January 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 399930 LOT #V030448 IMPLANTED: (B)(6) 2007 EXPLANTED: NA, EXTENSION MODEL 3708220 (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA, PROGRAMMER MODEL 37742.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD COUPLING/COMMUNICATIONS ISSUES WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND AN OVERDISCHARGE WAS SUSPECTED. THE PATIENT INDICATED THAT THEY HAD A PRIOR OVERDISCHARGE EVENT IN THE PAST. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT ALSO EXPERIENCED NO STIMULATION SENSATION AND THE OVERDISCHARGE CONDITION ON THE INS WAS CONFIRMED DUE TO THE PATIENT NON-COMPLIANCE. A PHYSICIAN MODE RECHARGE (PMR) PROCEDURE WAS PERFORMED BUT WAS NOT ABLE TO RESET THE INS. IT WAS CLARIFIED THAT THIS WAS THE SECOND OR POSSIBLY THIRD OVERDISCHARGE CONDITION ON THEIR INS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS UNABLE TO BRING THE INS OUT OF THE OVERDISCHARGE CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1