BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2821749 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09977
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 355029, LOT# N123541, IMPLANTED: (B)(6) 2007, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BACK SURGERY IN (B)(6) DURING WHICH HIS LEADS WERE 'MESSED UP.' THE SURGERY WAS FOR STENOSIS AND ARTHRITIS AND THE PATIENT HAD A FUSION DONE. THE PATIENT'S STIMULATOR HELPED THE LUMBAR PAIN BEFORE THE HCP (HEALTH CARE PROFESSIONAL) DISCONNECTED THE LEADS. STIMULATION HAD BEEN OFF SINCE (B)(6) AND THE PATIENT HAD BEEN TO SEVERAL HCP'S WHO WOULD NOT REVISE THE LEADS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1