BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE STIMULATOR

    MDR report key: 2885134 · Received December 26, 2012

    Report

    Report Number
    3007566237-2012-03108
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD. DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR IS MOTOR CORTEX STIMULATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SPASMS DURING A CT SCAN WHEN THE STIMULATION HAD BEEN TURNED OFF. ADDITIONAL INFORMATION HAS BEEN RE QUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3007566237-2012-03107. IT WAS UNCLEAR WHICH DEVICE THE SYMPTOMS WERE RELATED TO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED LAST TIME THE PATIENT HAD BEEN SEEN BY THE MANUFACTURER REPRESENTATIVE WAS ON (B)(6) 2012 AND HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPROGRAMMED THEN. IT WAS STATED THAT THE SYSTEM WAS WORKING AS DESIGNED AND THERE WERE NO IMPEDANCE ISSUES. THE PATIENT USED THE STIMULATION TO TRY AND DEFUSE THE SPASMS SHE HAD, HER DISEASE HAD PROGRESSED TO THE POINT THAT THE DEVICE WAS UNABLE TO HELP HER. HER HEALTHCARE PROFESSIONAL (HCP) "KEPT TRYING TO WORK WITH IT AND HER AND WAS NOT SURE WHAT TO DO NEXT." THE HCP HAD TRIED LOWERING HER PULSE WIDTH AND PUTTING HER AT A HIGHER PULSE RATE WITH NO EFFECT. IT WAS STATED THAT THE PATIENT WAS TO HAVE AN APPOINTMENT ON THE DAY OF THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1