BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2998164 · Received March 11, 2013

    Report

    Report Number
    6000032-2013-00059
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3888-28, LOT# J0225319V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT'S DEVICE WAS REPLACED, THE PATIENT WAS RECEIVING GOOD STIMULATION AND GOOD THERAPY. PLEASE REFER TO MFR. REPORT # 3004209178-2013-03643 REGARDING PATIENT'S NEW DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES BEFORE THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY, AS WELL AS A LOW BATTERY STATUS. IT WAS STATED THAT THE READINGS WERE AS FOLLOWS: "GREATER THAN 4000 OHMS ON ALL OF THE UNIPOLAR PAIRS. ALL PAIRS WERE GREATER THAN 4000 OHMS WITH CASE. BIPOLAR PAIRS WERE 01=1500, 02 "?", 03 2800; 12=1500; 13="?", 23=1500." IT WAS ALSO STATED THAT THE PATIENT WAS CURRENTLY ON PROGRAM C+3-. ADDITIONAL INFORMATION WAS REQUESTED, AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101120 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1