BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3466816 · Received November 13, 2013

    Report

    Report Number
    3004209178-2013-20701
    Event Type
    Injury
    Date Received
    November 13, 2013
    Report Date
    October 25, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS REMOVED SINCE THEY WERE NO LONGER USING THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) GOT WARM AT INCREASED AMPLITUDES AND THEY HE HAD NOTICED URINARY INCONTINENCE WITH STIMULATION TURNED ON. WARMTH OCCURRED AT IPG SITE AND DEVICE POCKET. THE HEALTH CARE PROFESSIONAL REQUESTED REPROGRAMMING ON (B)(6) 2013. IMPEDANCES WERE NORMAL. PERFORMED A SKIN TEMPERATURE CHECK AT THE START OF THE SESSION AND GOT 90.1 F. EIGHT (8) MINUTES LATER THEY FOUND 93.1 F. HEALTH CARE PROFESSIONAL SCHEDULED X RAYS AND SCHEDULED A FOLLOW-UP FOR (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT OPTED FOR A PUMP TRIAL INSTEAD OF THE IPG REVISION. IT WAS SUCCESSFUL AND HE WOULD HAVE PUMP IMPLANT ON (B)(6) 2014. NO OTHER INFORMATION WAS AVAILABLE ON THE IPG SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588220 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