BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2941541 · Received February 4, 2013

    Report

    Report Number
    9614453-2013-00031
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    December 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT WAS NOTED AS 2011, NO MONTH OR DAY GIVEN. MODEL# 8870BBO SERIAL# (B)(4) IMPLANTED: N/A, EXPLANTED N/A. PRODUCT TYPE: SOFTWARE CARD, PROGRAMMER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) DELIVERED INTERMITTENT STIMULATION. WHEN THE INS WAS PROGRAMMED TO CYCLE STIMULATION 1 HOUR ON, 1 HOUR OFF, THE STIMULATION DID NOT TURN ON AGAIN "IN A RANDOM WAY." THE PATIENT DID NOT NOTICE A PARTICULAR PLACE OR ACTIVITY THAT CAUSED THE "NON RESTART." WHEN THE STIMULATION WOULD NOT RESTART, THE PATIENT HAD TO TURN STIMULATION OFF AND BACK ON WITH THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION RECEIVED ABOUT 5 WEEKS LATER REPORTED THE EVENT DID NOT SEEM POSTURE RELATED. DURING A TEST (SUGGESTED TEST WAS CYCLING 5 MINUTES OFF, 5 MINUTES ON) WITH THE PHYSICIAN, THE "NON RESTART" DID NOT OCCUR. PATIENT STATUS WAS NOTED AS NO INJURY/NO ADVERSE EVENT. NO SYMPTOMS WERE NOTED RELATED TO THE EVENT. THE DEVICE WAS REPROGRAMMED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE HIGH IMPEDANCES. CONTACT 0 HAD A MEASURED IMPEDANCE OF GREATER THAN 4,000 OHMS. THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46601 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7425

    Patients

    Seq Age Sex Outcome Treatment
    1