BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1950338 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-10482
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 3, 2010
    Report Date
    November 8, 2018
    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
    CA, US
    Reporter Occupation
    003
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELT STIMULATION IN THE WRONG LOCATION AND A SURGING SENSATION. SHE FELT STIMULATION IN HER BACK AND THEN WHEN SHE LEANED FORWARD SHE FELT IT IN HER ABDOMEN. SOME BIPOLAR PAIRS HAD IMPEDANCE GREATER THAN 4,000 OHMS. THE 8-15 PORT WAS BEING USED THOUGH THE PT THOUGHT SHE FELT THE SYMPTOMS WHEN 0,3 WAS PROGRAMMED. THE PHYSICIAN FELT HE SAW A FRACTURE OF ONE OF THE EXTENSIONS AND THE PT WAS SCHEDULED FOR EXPLORATORY SURGERY. IT ALSO APPEARED THAT "THE WIRES CONNECTING TO THE BATTERY WERE COMING OUT." FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention "SEE H10...."| ACCESSORY: MODEL 37752, LOT# NKA020485N,| EXTENSION: MODEL 37082, LOT# NKB003710N,| EXTENSION: MODEL 37082, LOT# NKB003711N,| IMPLANTED:| IMPLANTED: | IMPLANTED: | LEAD: MODEL 3999, LOT# V000596,| PROGRAMMER: MODEL 37742, LOT# NJD035156N,| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA020485N,| EXTENSION: MODEL 37082, LOT# NKB003710N,| EXTENSION: MODEL 37082, LOT# NKB003711N,| IMPLANTED:| LEAD: MODEL 3999, LOT# V000596,| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD035156N,