BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 3133713 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08232
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF-LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS URINARY DYSFUNCTION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: EXTENSION: PRODUCT ID 3093-28, LOT# V577516, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3093-28, LOT# V577516, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 12 SURGERIES, HAD MS, THAT THE PATIENT'S HUSBAND DROVE HER BACK AND FORTH EVERY MONTH TO LA TO SEE HER PHYSICIAN, AND SHE WAS NOT HAVING SUCCESS WITH HER THERAPY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT RECEIVED ANY RELIEF AND SHE HAD TO CATHETERIZE HERSELF BECAUSE SHE COULD NOT URINATE AT ALL. IT WAS THOUGHT THAT THE PATIENT WAS STILL HAVING PROBLEMS AND THE PATIENT HAD THE DEVICE IMPLANTED AND REMOVED AND PUT IN AGAIN. SUPPLEMENTAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S PHYSICIAN NOTED CAUSE OF EVENT AS ¿BADDENED OBSTRUCTION.¿ AN EXPLANT OF THE ENTIRE SYSTEM FOR LEG PAIN WAS REPORTED. THE PATIENT¿S SYMPTOMS WERE REPORTED AS LEG PAIN AND PAIN AT THE INCISION. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236321 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention