BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3872063 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11555
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    December 17, 2008
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3887-28, LOT# L68179, IMPLANTED: 1999 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 1999 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS NOTED THE PATIENT HAD NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS FURTHER NOTED, THE PATIENT LAST FELT STIMULATION ON 2008 (B)(6). THE REPORTER STATED THEY WERE NOT ABLE TO ADJUST STIMULATION. IT WAS FURTHER NOTED THE PATIENT USED RECHARGEABLE BATTERIES AND THEY APPEARED TO BE FINE. THE REPORTER FURTHER STATED THEY DID NOT HAVE ANY OTHER BATTERIES. IT WAS NOTED, THE PATIENT HAD HIGH SETTINGS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROFESSIONAL. IT WAS NOTED, THE PATIENT DEVICE WAS NOT REPROGRAMMED AND THE PATIENT PROGRAMMER WAS NOT REPLACED. IT WAS FURTHER NOTED, THE PATIENT HAD OR WOULD BE HAVING SURGERY TO FIX THE PROBLEM WITH THEIR SYSTEM. THE REPORTER STATED, THEY WERE STILL HAVING PROBLEMS WITH THEIR SYSTEM AND THE PROBLEMS WERE RELATED TO THE BATTERY. ADDITIONAL INFORMATION RECEIVED REPORTED, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT FUNCTIONING DUE TO BATTERY FAILURE. THE REPORTER STATED, THE BATTERY HAD "EXHAUSTED." IT WAS NOTED, THE PATIENT HAD THEIR INS REPLACED ON 2009 (B)(6). IT WAS FURTHER NOTED, THE PATIENT HAD A HISTORY OF LOW BACK AND LOWER EXTREMITY PAIN AND THEY HAD UNDERGONE MULTIPLE PROCEDURES IN THE PAST. THE REPORTER STATED, THE PATIENT TOLERATED THE REPLACEMENT PROCEDURE WELL AND THEY WERE TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349007 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention