BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3841384 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01493
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 39565-65, LOT# 0207911945, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S LEAD MIGRATED. IT WAS STATED THE LEAD WAS INITIALLY IMPLANTED AT T11-T12 LEVEL AND DIRECTLY CONNECTED TO THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT FELT STIMULATION AT THE THORACIC LEVEL AND NOT IN THEIR LOWER LIMBS WHILE SET AT 1.5 VOLTS. IT WAS NOTED THE PATIENT HAD PAIN AT BOTH LEVELS. IT WAS FURTHER REPORTED THAT WHEN SET TO 3 VOLTS THE PATIENT ALSO FELT THE STIMULATION IN HIS LEGS. IT WAS STATED THE STIMULATION WAS TOO STRONG FOR THE THORACIC LEVEL. IT WAS ALSO STATED THE PATIENT EXPERIENCED LESS THAN 50% THERAPEUTIC RELIEF. AN X-RAY INDICATED THE PATIENT¿S LEAD HAD MIGRATED TO THE CERVICAL LEVEL. IT WAS REPORTED THE PATIENT¿S PHYSICIAN DID NOT PLAN TO REVISE THE LEAD AT THE TIME OF INITIAL REPORT. IT WAS NOTED THE PATIENT HAD A HISTORY OF PREVIOUS LEADS (THAT WERE PRODUCED BY OTHER MANUFACTURERS) MIGRATING. IT WAS REPORTED THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS NOT RECEIVING THERAPY AT THE TIME OF FOLLOW-UP. IT WAS NOTED THAT THE PATIENT¿S DOCTORS WERE ¿WAITING¿ AND THAT ¿NO DECISIONS HAD BEEN TAKEN" AT THE TIME OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318693 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1