BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3092124 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01518
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A "LOW OUT OF RANGE IMPEDANCE VALUE." IT WAS FURTHER REPORTED THE PATIENT WAS IN THE OPERATING ROOM FOR A TRIAL AND IMPEDANCE VALUES AT 1.5 VOLTS SHOWED LESS THAN 50 OHMS FOR "SOME OF THE 8-15 CONTACTS." CONTACTS 0-7 WERE NOTED TO BE "OK" AND IT WAS STATED THE PATIENT WAS "GETTING GOOD STIMULATION WITH THOSE." THE IMPEDANCE TEST WAS REPEATED AT 3.0 VOLTS AND IT WAS STATED "ALL COMBOS WERE SHOWING LESS THAN 150 OHMS." IT WAS NOTED THAT "NO SALINE WAS USED." ADDITIONAL INFORMATION STATED THEY "REPOSITIONED THE LEAD IN THE MULTI-LEAD TRIALING CABLE" AND THAT THIS "RESOLVED THE ISSUE." IT WAS RESTATED THAT THE LEAD WAS "SEATED IN THE MULTI-LEAD TRIALING CABLE" AND WAS "REPOSITIONED." IT WAS NOTED THE PATIENT'S OUTCOME WAS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194198 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1