BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2831569 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10239
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 399930 LOT# V043269, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCESS OF FOLLOWING UP ON THE EVENT, THE MANUFACTURER'S DEVICE REGISTRY INDICATED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2012. FURTHER FOLLOW UP REPORTED THAT THE PATIENT'S CAUSE WAS COPD, CORONARY ARTERY DISEASE, AND CHRONIC RENAL FAILURE. THE DEATH WAS NOT CONSIDERED TO BE RELATED TO THE IMPLANTABLE NEUROSTIMULATOR DEVICE SYSTEM. MULTIPLE ATTEMPTS AT CONTACTING THE PATIENT'S HEALTHCARE PROFESSIONAL REGARDING THE PATIENT'S DEATH WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A URINARY TRACT INFECTION AND WAS CURRENTLY IN AN ASSISTED LIVING FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention