BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3015862 · Received March 21, 2013

    Report

    Report Number
    3004209178-2013-04074
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3487A-33, LOT# V000574, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-33, LOT# V000574, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE FELT NO STIMULATION SENSATION. THE PATIENT WAS PLAYING CARDS AT THE TABLE LAST FRIDAY WHEN THE STIMULATION STOPPED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHARGED AND THE PATIENT PROGRAMMER SHOWED THAT STIMULATION WAS TURNED ON. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE LOSS OF STIMULATION. THE PATIENT REPORTED SHE HAD AN APPOINTMENT WITH HER PHYSICIAN THAT DAY. THE NEXT DAY THE COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT STILL HAD NO STIMULATION SENSATION. STIMULATION WAS TURNED UP TO 10.3V AND 8.6V WITH NO CHANGE. GROUP IMPEDANCES A1 AND A2 WERE BOTH >3600 OHMS FOR BOTH PROGRAMS. ELECTRODE 11 ALSO SHOWED IMPEDANCES >3600 OHMS. THE PATIENT WAS REPROGRAMMED TO AVOID ELECTRODE 11 AND THE PATIENT FELT STIMULATION IN THE CORRECT LOCATION AND WAS GETTING GOOD THERAPEUTIC BENEFIT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118753 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR