BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2820094 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09938
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING AN IMPLANT PROCEDURE FOR THE IMPLANTABLE NEUROSTIMULATOR (INS), THE PHYSICIAN WAS HAD TROUBLE STEERING THE LEAD COMPONENT WHEN USING THE STYLET. IT WAS NOTED THAT THE LEAD WAS PRELOADED WITH BENT STYLET. THE PHYSICIAN TRIED ADJUSTING THE TENSION ON THE STYLET BY RELEASING IT FROM THE GROOVED HANDLE, THEN RETRACTING IT. WHEN THE DOCTOR ATTEMPTED RELOAD THE STYLET INTO THE GROOVED HANDLE THE LAST FEW INCHES WOULD ADVANCE AND KEPT HANGING UP ON THE DISTAL SEGMENT OF THE LEAD (WHICH HAD A SLIGHT CURVE). HE THEN CHANGED THE STYLET, RELOADED INTO THE LEAD BUT IT WOULD STILL NOT ADVANCE PAST THE CURVED DISTAL SEGMENT OF THE LEAD. THE PHYSICIAN DID NOT ATTEMPT TO MANIPULATE THE LEAD DURING THE IMPLANT. THE PHYSICIAN THEN REQUESTED A NEW LEAD WHICH WAS THEN IMPLANTED INTO THE PATIENT WITHOUT ANY DIFFICULTY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1