BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1910089 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-09947
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    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

    THE PT EXPERIENCED INCREASING PAIN AND FEVER. SHE WAS TRAVELLING IN (B)(6) AT THE TIME AND WAS ADMITTED TO A (B)(6) HOSPITAL WHERE SHE WAS FOUND TO BE SEPTIC AND HEMODYNAMICALLY UNSTABLE, REQUIRING VASOPRESSORS TO CONTROL HER BLOOD PRESSURE. URINALYSIS SHOWED 50-100 WBC'S AND SHE HAD SKIN ABRASIONS ON HER HIP AND BUTTOCK AREA. SHE WAS STABILIZED AND TRANSFERRED BACK TO (B)(6) TO THE CARE OF HER REGULAR FOLLOW-UP PHYSICIAN. THE SYSTEM WAS REMOVED AND THE PT WAS IN THE PROCESS OF RECOVERING. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    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 69 YR Hospitalization| R IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE157244N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# V388273| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008021V| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008020V| IMPLANTED:| LEAD: MODEL 3888, LOT# V546812| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V546812| EXPLANTED:| LEAD: MODEL 3887, LOT# V388273| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA143672N