BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2671735 · Received July 26, 2012

    Report

    Report Number
    3004209178-2012-06151
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N312844, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ACUTE "FLARE UP" IN THEIR RIGHT LEG WHERE HE USUALLY HAD PAIN. HE DID NOT FEEL ANY STIMULATION AT 10.5 AMPS, BUT IMPEDANCES WERE IN THE 800-900 OHM RANGE. IT DID NOT SEEM TO MAKE A DIFFERENCE WITH STIMULATION ON OR OFF. A1: NO AMPLITUDE PROGRAMMED. A2 226OHMS AND >35.0 CURRENT. THE PATIENT HAD A LOT OF SCAR TISSUE. THERE WAS MINIMUM MIGRATION OF LEAD, BUT NOTHING SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR