BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 3082774 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01461
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN DECIDED THE PATIENT'S STATEMENT OF THE "WIRES COMING OUT OF HER" IS NOT AN ALLEGATION, BUT INSTEAD A DESCRIPTION OF THE TRIAL LEADS THAT NORMALLY COME OUT OF A PATIENT. THE PATIENT'S COMPLAINT IS AGAINST THE LEADS "STARTING TO BREAK OFF" OF THEIR EXTERNAL NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT ¿THOUGHT THAT THE LEADS WERE PULLING OUT OF THE EXTERNAL NEUROSTIMULATOR DURING HER TRIAL.¿ IT WAS NOTED THAT THE PATIENT¿S PHYSICIAN ¿CHECKED THE LEADS AND THEY WERE IN PLACE¿ AND THAT ¿NO ISSUE WAS FOUND WITH HER LEADS.¿ IT WAS STATED THERE PATIENT EXPERIENCED ¿NO INTERRUPTION TO HER THERAPY¿ AND THE ¿TRIAL WENT WELL.¿ THE PATIENT WAS NOTED TO HAVE BEEN PERMANENTLY IMPLANTED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIAL THE PATIENT'S "WIRES COMING OUT OF THEM AND WERE STARTING TO BREAK OFF OF THE THING." NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185536 UNKNOWN EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1