BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1932076 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10021
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 18, 2010
    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

    SEE MFR # 3004209178-2010-10020. THE PT WAS CHARGING MORE THAN EXPECTED IN THE PAST TWO WEEKS. SHE HAS BEEN CHARGING TWICE AS MUCH THAN THE LAST IMPLANT. CHARGING TIME WENT FROM 1.5 HRS WITH THE PRIOR IMPLANT TO 4 HRS WITH THE CURRENT IMPLANT. TWO RECHARGERS HAVE BEEN TRIED. SHE RECHARGES BOTH NEUROSTIMULATORS (INS) AT THE SAME TIME. AN OVER STIMULATION SENSATION WAS EXPERIENCED DURING AN IMPEDANCE MEASUREMENT, WHICH HAS NOT OCCURRED BEFORE DURING A GROUP MEASUREMENT. SHE HAS ONE PROGRAM AND ELECTRODES 0-7 ARE OKAY. THE ONLY INTACT ELECTRODE OUT OF 8-15 WAS 11. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 10,000 OHMS. THE STIMULATION USED TO BE COMFORTABLE BUT IT BECAME UNCOMFORTABLE. SHE FELT A WEIRD SENSATION. THE LEADS APPEARED TO NOT BE TOUCHING EACH OTHER. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 57 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37713,| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# N266531| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB056253V| IMPLANTED:| LEAD: MODEL 3778, LOT# V217923037| EXTENSION: MODEL 37081, LOT# NJB056250V| LOT# NJK716268H| PROGRAMMER: MODEL 37743, LOT# NKE104806N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB034840V| LEAD: MODEL 39565-30, LOT# N144885001| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA145236N| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB029624V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V550636006| PROGRAMMER: MODEL 37743, LOT# NKE155713N| EXPLANTED:| EXPLANTED: