BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3091918 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01516
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD . (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR PHYSICIAN AND MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. AN APPOINTMENT OF (B)(6) 2013 WAS NOTED.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, IT WAS REPORTED THAT THEY TOOK ¿THE OTHER SIDE OUT¿ BECAUSE IT GOT INFECTED; PART OF THE WIRE CAME STICKING OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT HAD A LEFT SIDE IMPLANT, AND AFTER THE PATIENT WENT HOME SHE FELT SOMETHING ON THE BACK OF HER HEAD AND WENT BACK TO THE HOSPITAL. THE REPORTER STATED THAT THEY FOUND THAT A PIECE OF WIRE HAD POPPED OUT OF THE SKIN ON THE BACK OF HER HEAD. ON (B)(6) 2013, THE DEVICE WAS REMOVED FROM THE LEFT SIDE. THE PATIENT'S RIGHT SIDE DEVICE REMAINED IMPLANTED. IT WAS REPORTED THAT THE LEFT SIDE WOULD BE RE-IMPLANTED ON (B)(6) 2013. 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
    193695 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention