BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1910644 · Received November 19, 2010

    Report

    Report Number
    3004209178-2010-09832
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 12, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TWO MONTHS AGO, THE PT BENT OVER WHEN SITTING ON A BED AND HEARD/FELT A POP. AFTER THAT SHE STOPPED FEELING STIMULATION; HER ARM WENT NUMB; THE DEVICE SYSTEM HAS NOT WORKED AT ALL. SHE WENT TO THE ER AND AN X-RAY WAS PERFORMED OF THE DEVICE SYSTEM WHICH LOOKED FINE. SINCE THE ER VISIT, SHE HAS EXPERIENCED VOMITING AND NAUSEA. THE LABS LOOKED FINE. SHE WENT TO THE HOSPITAL ON (B)(6) 2010. SHE LOST WEIGHT DUE TO A LEG AMPUTATION ON (B)(6) 2006 WHICH HAS CAUSED HER DEVICE TO STICK OUT. THERE WERE COUPLING AND OR COMMUNICATION ISSUES. SHE LAST RECHARGED 2 MONTHS AGO AND THE DEVICE WAS OVERDISCHARGED. THE POOR COMMUNICATION SCREEN DISPLAYED ON THE PT PROGRAMMER. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization LEAD: MODEL 3778, LOT # V010400| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB005649V| PROGRAMMER: MODEL 37742, LOT# NJD027562N| EXPLANTED:| EXPLANTED: