BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3455334 · Received November 7, 2013

    Report

    Report Number
    3004209178-2013-20349
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Report Date
    October 17, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377645, LOT# V002451, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377645, LOT# V002451, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3887-33, LOT# J0343933V, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# J0340513V, IMPLANTED: 2003 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6) ; PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. IN 2008, THE PATIENT HAD A BIOPSY FOR BREAST CANCER AND FELT LIKE SHE WAS ¿BEING ELECTROCUTED¿ DURING THE PROCEDURE. STIMULATION WAS ON DURING THE PROCEDURE AND WAS UNSURE IF ELECTRO CAUTERY WAS USED OR NOT. PATIENT HAD HAD MRI¿S IN THE PAST DUE TO BREAST CANCER. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577326 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 00048 YR