BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3103221 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07469
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 16, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A-33 LOT# J0222678V, IMPLANTED: 2002 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 7495-66 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 7495-66 LOT# SERIAL# (B)(4), IMPLANTED: 2002 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3487A-45 LOT# J0211735V, IMPLANTED: 2002 (B)(6),2013-04-11 PRODUCT TYPE LEAD PRODUCT ID: 7435 LOT#, NFT021640P, IMPLANTED: 2002 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION FOR THIS EVENT WAS ALSO REPORTED IN MANUFACTURING REPORT # 6000144-2013-00008. ALL ADDITIONAL INFORMATION PERTAINING TO THIS EVENT WILL BE REPORTED IN THIS FILE. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED IN (B)(6) 2013, THE PATIENT HAD NO STIMULATION SENSATION. IMPEDANCES WERE CHECKED BEFORE THE PATIENT'S PRIOR DEVICE WAS REPLACED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. IT WAS NOTED, THE PATIENT "MIGHT HAVE FELT STIMULATION POST REPLACEMENT BUT WAS NOT SURE SINCE HE WAS UNDER GENERAL ANESTHESIA." THE PATIENT DID NOT FEEL STIMULATION WHEN IT WAS PROGRAMMED AT 10.5 VOLTS (V) "8-11" FOR PERIPHERAL OCCIPITAL STIMULATION. IT WAS ALSO REPORTED, THE PATIENT WAS ABLE TO FEEL MINIMAL STIMULATION. CURRENT IMPEDANCES MEASUREMENTS WERE WITHIN THE NORMAL RANGE, APPROXIMATELY 2000 OHMS, WHEN CHECKED AT ALL LEVELS. IT WAS NOTED, THE PULSE RATE WAS ALSO INCREASED TO 130 HERTZ (HZ) AND THE PATIENT WAS STILL UNABLE TO FEEL STIMULATION AT 10.5 V. FLUOROSCOPIC IMAGES OBTAINED ON (B)(6) 2013, WERE REVIEWED AND NO ELECTRODE MIGRATION WAS NOTED. ADDITIONAL INFORMATION RECEIVED 7 WEEKS LATER REPORTED THE PATIENT'S LEAD WAS REPLACED ON (B)(6) 2013, AND REPROGRAMMING WAS PERFORMED. THE PATIENT RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203455 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention