BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3845017 · Received June 3, 2014

    Report

    Report Number
    6000032-2014-00109
    Event Type
    Injury
    Date Received
    June 3, 2014
    Report Date
    May 9, 2014
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A, LOT# L65524, IMPLANTED: 1999 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: 1999 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: 1999 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT LAST AS LONG AS IT WAS SUPPOSED TO. INFORMATION OMITTED PERTAINING TO EVENTS (B)(4) - OVER-DISCHARGE/COUPLING, (B)(4) AND (B)(4) REGARDING PRIOR INSS NOT LASTING AS LONG AS THEY SHOULD. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF REPORTED AND WILL BE UPDATED WHEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED BY THE PATIENTS PHYSICIAN THAT EPIDURAL FIBROSIS WAS SUSPECTED, SINCE THE STIMULATOR WAS NOT AS EFFECTIVE AS BEFORE. IT WAS STATED THAT THE BATTERY WAS OK, NO MALFUNCTIONS OR CAUSE SEEN. WHEN THE BATTERY WAS REPLACED ON (B)(6) 2004, A SECOND LEAD WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323752 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 00070 YR Required Intervention