BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3112358 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07651
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    May 8, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377860, LOT# V006400, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377860, LOT# V006400, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPEDANCE CHECK REVEALED FOUR CONTACTS "OUT" ON ONE LEAD AND ANOTHER CONTACT OUT ONTHE OTHER.  ATTEMPTS TO REPROGRAM AROUND THE BAD CONTACTS WERE UNSUCCESSFUL.  AN X-RAY WAS UNREMARKABLE FOR ANY LEAD MIGRATION.  A FUTURE LEAD REVISION IS TO BE SCHEDULED.  THE PATIENT IS STILL RECEIVING STIMULATION AS BEFORE AND VERBALLY INDICATED AN UNDERSTANDING OF WHAT IS REQUIRED TO FIX HER CURRENT SITUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS ADDED THIS OCCURRED "APPROXIMATELY 3-4 TIMES A DAY." IT WAS STATED THE PATIENT FELT STIMULATION NORMALLY, UNTIL THE "SPORADIC" SHOCKS. IT WAS NOTED THAT REPROGRAMMING WAS ATTEMPTED BUT THE PATIENT "DIDN¿T LIKE THE COVERAGE." IT WAS STATED THE PATIENT WAS PROGRAMMED AS ¿DOUBLE GUARDED CATHODE ON EACH LEAD, USING 0-3 ON FIRST AND 9-12 ON THE SECOND LEAD.¿ IT WAS NOTED IMPEDANCES WERE >3600 OHMS ON VARIOUS CONTACTS. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213217 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1