BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1083607 · Received July 29, 2008

    Report

    Report Number
    9614453-2008-04452
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    March 17, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEUROSTIMULATOR AND EXTENSION WERE RETURNED FOR ANALYSIS. DEVICE ANALYSIS REVEALED THE NEUROSTIMULATOR (INS) WAS FUNCTIONALLY ACCEPTABLE. THERE WAS A COSMETIC CUT IN THE ACCESS HOLE ADHESIVE OVER THE #3 CONNECTING WIRE. FOREIGN MATERIAL IN CONNECTOR PORT(S). THE GROMMET LEAKAGE TEST WAS DONE WITH THE RETURNED EXTENSION. ALL THE IMPEDANCES WERE NORMAL EXCEPT THE #3 CIRCUIT WHICH SHOWED AN IMPEDANCE OF 77K OHMS. WHEN THE PORTION OF THE EXTENSION THAT HAD THE BREACHED CUT IN IT WAS PULLED OUT OF THE SALINE SOLUTION, THE IMPEDANCE WENT UP TO 1.08M OHMS. THIS INDICATED THAT THERE WERE NO LEAKAGE PATHS IN THE CONNECTOR AREA, HOWEVER, THERE WAS A LEAKAGE PATH THROUGH THE BREACHED CUT IN THE EXTENSION INSULATION AT 8.0 CM FROM THE PROXIMAL END. THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR INCLUDING THE UNIPOLAR MODE. THE OUTPUT MATCHED THE PROGRAMMED SETTINGS. THERE WERE NO ISSUES WHEN PRESSING ON THE NEUROSTIMULATOR CAN. THE BATTERY STATUS SHOWN ON THE 8840 PROGRAMMER WAS ACCEPTABLE. DEVICE ANALYSIS OF THE EXTENSION REVEALED THERE WAS A BREACHED CUT IN THE INSULATION 8.4 CM FROM THE PROXIMAL END. THERE WAS SUSPECTED BODY FLUIDS IN THE LUMEN OF THE #3 CONDUCTOR ALONG THE LENGTH OF THE EXTENSION. THE EVIDENCE SUGGESTED THAT THIS BREACHED CUT MAY HAVE OCCURRED WHEN THE FIRST NEUROSTIMULATOR WAS REPLACED AND SUBSEQUENTLY MAY HAVE RESULTED IN THE POCKET STIMULATION. (SEE SCANNED PAGE).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD REPLACEMENT SURGERY AFTER 5-6 YEARS OF SERVICE. THE PT EXPERIENCED PAIN AROUND THE IMPLANT POCKET AFTER REPLACEMENT SURGERY. A NEW NEUROSTIMULATOR AND EXTENSION WERE IMPLANTED. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC SWISS MANUFACTURING FACILITY 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| EXTENSION MODEL 7495 LOT#XR0000766V