BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2160820 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05192
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 13, 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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF STIMULATION FOLLOWING A MOTOR VEHICLE ACCIDENT. SHE ALSO STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD NOT HOLD A CHARGE. A CLINIC ATTEMPTED TO REPROGRAM THE INS WITHOUT SUCCESS. THE IMPEDANCE OF THE LEADS WAS TESTED AND THEY WERE BOTH FUNCTIONING. THE PT WAS ABLE TO FEEL STIMULATION SO THE HEALTH CARE PROFESSIONAL (HCP) DECIDED TO REPOSITION THE LEADS. DURING THE REVISION, THE HCP PULLED ON THE LEADS AND ELECTRODES 14 AND 15 PULLED NEARLY OUT OF THE INCISION OPENING. THESE ELECTRODES WERE FOUND TO HAVE IMPEDANCES <50 OHMS. THE HCP ELECTED TO LEAVE THE LEADS IMPLANTED BECAUSE THE PT WAS SILL VERY SORE FROM THE ACCIDENT WITH NEW PAIN. THE HCP ALSO SUGGESTED THAT THE INS BE PROGRAMMED WITHOUT USING ELECTRODES 14 AND 15. THE ISN WAS EXPLANTED AND REPLACED DURING THE REVISION. THE PT WAS NOT INJURED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention ACCESSORY: MODEL 37752, LOT# NKA152177N| EXPLANTED: | EXPLANTED: | EXPLANTED: | IMPLANTABLE NEURO STIMULATOR: MODEL 37713,| IMPLANTED: | IMPLANTED: | IMPLANTED: | LEAD: MODEL 3777, LOT# V604886032| LEAD: MODEL 3777, LOT# V652114006| LOT# NJK717497H| PROGRAMMER: MODEL 37743, LOT# NKE166789N| IMPLANTABLE NEURO STIMULATOR: MODEL 37713,| LOT# NJK717497H| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V652114006| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE166789N| ACCESSORY: MODEL 37752, LOT# NKA152177N| LEAD: MODEL 3777, LOT# V604886032