BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 3082916 · Received April 29, 2013

    Report

    Report Number
    6000032-2013-00109
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7433, SERIAL # (B)(4), IMPLANTED: (B)(6) 1992, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1992, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A, LOT # L21605, IMPLANTED: (B)(6) 1992, PRODUCT TYPE LEAD; PRODUCT ID 3587A, LOT # L21605, IMPLANTED: (B)(6) 1992, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN REMOVED 10 DAYS PRIOR TO THE REPORT DUE TO STIMULATION BEING IN THE WRONG LOCATION. IT WAS STATED THAT THE PATIENT WAS DISAPPOINTED TO LEARN THAT THE LEAD WAS NOT REMOVED ALONG WITH THE INS. IT WAS STATED THAT SHE HAD TOLD HER DOCTORS THAT SHE WANTED THE DEVICE REMOVED SINCE HER PAIN WAS THEN GONE, AND DUE TO THE LEAD MOVING AFTER "SHE HAD BEEN ZAPPED AT THE AIRPORT", AND TO AVOID COMPATIBILITY ISSUES WITH IMPLANTED DEVICES. IT WAS REPORTED THAT WHEN THE INS HAD BEEN EXPLANTED, THE LEAD WAS EMBEDDED IN THE SPINE DUE TO SCAR TISSUE BUILD UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183863 ITREL II STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R