BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2392472 · Received December 29, 2011

    Report

    Report Number
    3004209178-2011-10115
    Event Type
    Malfunction
    Date Received
    December 29, 2011
    Report Date
    December 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER: MODEL 37743, SERIAL# (B)(4). RECHARGER: MODEL 37752, SERIAL# (B)(4). LEAD: MODEL 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3777-60, SERIAL#(B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. ANCHOR: MODEL 3550-39, LOT# N213355.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COUPLING ISSUES WITH THEIR IMPLANTABLE NEUROSTIMULATOR. AN ANTENNA LOCATOR WAS USED AND RESULTED IN A POWER-ON-RESET CONDITION. A NORMAL CHARGING SCREEN WAS REACHED AND THE PATIENT RECEIVED PERFECT COUPLING. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THAT THE PATIENT'S PROGRAMMER WAS WORKING AND HAD NO ISSUES WITH ITS USE. PREVIOUSLY, SHE HAD LOST THE PROGRAMMER AND HAD TO BE SENT A NEW ONE. SHE STRUGGLES WITH THE USE OF THE EXTERNAL RECHARGER BUT WAS PERFORMING THE TASK CORRECTLY. DUE TO THE PATIENT'S SMALL SIZE SHE "STRUGGLED" TO MAINTAIN A GOOD CONNECTION DURING RECHARGING AND CONTINUALLY HAD TO REPOSITION HERSELF TO MAINTAIN THE HIGHEST LEVEL OF COUPLING. IT WAS ALSO NOTED THAT THE RECHARGER DID NOT LIE FLAT OVER HER IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO HER SIZE AND INS PLACEMENT LOCATION. 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 ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1