BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE STIMULATOR

    MDR report key: 3073277 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01406
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THE PATIENT HAD A " PHASE 2" IMPLANT DONE THE DAY OF REPORT. THE REPRESENTATIVE HAD TRIED TO ADJUST THE PATIENT "BUT THEN THE PATIENT HAD TO GO TO THE BATHROOM." PATIENT WAS NOW COMPLAINING OF ELECTRIC SHOCK. CALLER DECLINED WALKING THROUGH HOW TO USE THE PROGRAMMER AND WANTED TO CONTACT THE REPRESENTATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE. NO PATIENT HARM WAS REPORTED. NO INDICATION OF PRODUCT DEFECT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED ONCE THE PATIENT WAS PROGRAMMED THE SHOCKING SENSATION RESOLVED. IT WAS NOTED THE SHOCKING STARTED WHEN THE PATIENT GOT UP TO USE THE BATHROOM PRIOR TO BEING ¿COMPLETELY PROGRAMMED.¿ THE PATIENT WENT TO THE RESTROOM AND WHEN THEY WERE DONE THEY COMPLAINED OF SHOCKING. WHEN THE PATIENT LEFT THE SURGICAL CENTER THEY WERE FREE OF PAIN AND DID NOT HAVE SHOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174571 UNKNOWN IMPLANTABLE STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1