BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2943822 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01301
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: EXTENSION: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A, LOT# L67502, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION FROM HER DEVICE WHEN SHE WENT INTO "CERTAIN POSITIONS." FOR INSTANCE, WHEN THE PATIENT LAY DOWN AT THE BEAUTY SHOP, SHE FELT A SHOCK THROUGH HER WHOLE BODY. THE REPORTER INDICATED THAT THE PATIENT WANTED TO BE REPROGRAMMED AND WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER (HCP) THE FOLLOWING DAY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48509 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1