BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT LOW IMPEDANCE LEAD

    MDR report key: 1033619 · Received April 24, 2008

    Report

    Report Number
    6000153-2008-02201
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P84001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HE PT HAD RECEIVED SPINAL ANESTHESIA PRIOR TO SYSTEM PLACEMENT. SUBSEQUENTLY, THE PT DEVELOPED SYMPTOMS OF PARALYSIS AFFECTING THE LOWER LIMBS. THE FOLLOWING DAY THERE HAVE BEEN NO CHANGE TO THE PT'S CONDITION AND BOTH LEAD PRODUCTS WERE EXPLANTED. RESULTS OF MRI EXAM OF THE BRAIN AND SPINAL CORD HAD REVEALED NO ABNORMALITIES; THE SPINAL CORD HAD BEEN COMPLETELY INTACT. A WEEK LATER, THE PT BECAME RESPONSIVE; HIS CONDITION HAD IMPROVED AND THE PT WAS AMBULATORY AGAIN. THE PHYSICIAN HAD INDICATED TO THE FIELD STAFF THAT THE CONDITION HAD BEEN A CONVERSION DISORDER. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN. REFER TO MFR REPORT # 600153200802200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT LOW IMPEDANCE LEAD LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 3778 V080487038

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R LOT# NKF701783H IMPLANTED| EXPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 37712