BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2841866 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10621
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3887-33 LOT# J0343933V, PRODUCT TYPE LEAD PRODUCT ID, 3887-33 LOT# J 0343933V, PRODUCT TYPE LEAD PRODUCT ID, 377845 LOT# V003668, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37 742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708220 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

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT HAD NO CONCERNS REGARDING THEIR THERAPY OR DEVICE. IT WAS STATED THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROVIDER (HCP) AND THEIR CONCERNS WERE RESOLVED. IT WAS ALSO STATED, THE PATIENT STILL HAD CONCERNS ABOUT THEIR THERAPY OR DEVICE, BUT WAS WORKING WITH THEIR HCP TO RESOLVE THOSE CONCERNS. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO OF THREE LEADS WERE NOT WORKING AND THE PATIENT WAS IN "A LOT OF PAIN." THE PATIENT REPORTEDLY HAD 3 MAJOR SURGERIES "THIS YEAR." IT WAS STATED THAT THE DOCTOR WANTED TO REPLACE THE LEADS BUT THE PATIENT WAS "TOO WEAK DUE TO CANCER AND HER CHEMOTHERAPY AND HER BLOOD PLATELETS WERE TOO LOW FOR SURGERY." IT WAS NOTED THAT THE PATIENT LOST HER PROGRAMMER. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1