BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2933229 · Received January 29, 2013

    Report

    Report Number
    3007566237-2013-00304
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A HEMORRHAGE AFTER THE LEAD WAS IMPLANTED IN THE SPINE AND THEY COULD NOT MOVE THEIR LEGS POST-OPERATION. THE REPORTER STATED THAT THE DOCTOR DESCRIBED IT AS PARAPLEGIA. THE LEAD WAS WITHDRAWN FROM THE PATIENT. IT WAS STATED THAT THE LEAD WAS ABANDONED, CAPPED, OR PARTIALLY REMOVED. IT WAS NOTED THAT "THE PROCEDURE OF IMPLANTATION OF THE LEAD WAS THE GOOD ONE, NOT THE FIRST THAT THE DOCTOR USE." IT WAS NOT CLEAR IF THIS MEANT THAT THE DOCTOR HAD TO USE A DIFFERENT LEAD, OR IF THIS MEANT THAT THIS WASN'T THE FIRST PROCEDURE THE DOCTOR HAS DONE. IT WAS LATER REPORTED THAT THE LEAD HAD BEEN WITHDRAWN FROM THE PATIENT "4 HOURS AFTER THE CASE." THE PATIENT RE-GAINED ALL OF THEIR LEG SENSATIONS AND WAS ABLE TO WALK NORMALLY. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38738 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention| S