BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2870443 · Received December 12, 2012

    Report

    Report Number
    3004209178-2012-11755
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 19, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37092, LOT# 283350001, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THAT PATIENT'S HEALTH CARE PROVIDER (HCP) SHOWED THE CAUSE OF THE EVENT WAS THAT THE PATIENT LOST THEIR PATIENT PROGRAMMER AFTER SURGERY AND WAS UNABLE TO TURN THEIR DEVICE ON POST OPERATIVELY. ONCE THE PATIENT PROGRAMMER WAS FOUND, THE PATIENT WAS ABLE TO TURN STIMULATION BACK ON AND THE DEVICE WAS "WORKING WELL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HE WAS UNABLE TO ADJUST ANY OF HIS PROGRAMS. THE PROBLEM OCCURRED FOLLOWING AN UNRELATED HIP REPLACEMENT SURGERY ON (B)(6) 2012. IT WAS BELIEVED THAT THE DEVICE WAS TURNED OFF PRIOR TO THE SURGERY AS THE PATIENT DID NOT BRING ANY OF HIS EQUIPMENT. THE PATIENT HAD BEEN IN REHAB FOR ONE WEEK PRIOR TO THE REPORT AND COULD NOT ADJUST HIS STIMULATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT HAD NOT BEEN SEEN IN THIS PARTICULAR HEALTH CARE PROVIDER'S OFFICE SINCE (B)(6) 2011. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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