BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4913025 · Received July 14, 2015

    Report

    Report Number
    3004209178-2015-13353
    Event Type
    Injury
    Date Received
    July 14, 2015
    Report Date
    June 26, 2015
    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

    CONCOMITANT PRODUCTS: PRODUCT ID: 37742,SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 399930, LOT# V043269, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 399930, LOT# V043269, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED AN MRI OF THE HEAD. THE PATIENT NEEDED THE MRI DUE TO A SMALL ANEURYSM, AND IT WAS NOTED THAT THE MRI WAS NOT RELATED TO THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED BECAUSE IT WAS NOT HELPING HER, AND THE LEADS WERE LEFT IN THE PATIENT¿S BODY. IT HAD HELPED A LITTLE BIT AT FIRST, BUT IT HAD STOPPED HELPING HER BECAUSE ¿THERE MIGHT BE THAT ONE OF THE LEADS KIND OF MOVED.¿ THAT¿S WHY THEY ¿SAWED¿ THEM IN SO THAT THEY WOULD STAY WHERE THEY WERE SUPPOSED TO BE, BUT THAT DID NOT RESOLVE THE ISSUE. IT WAS LATER EXPLAINED THAT THE LEADS HAD REMAINED IN THE PATIENT¿S BODY BECAUSE THEY WERE SEWN IN. THE DOCTOR HAD REQUESTED AN ANGIOGRAM (MRA), AND A COMPATIBILITY GUIDELINES REQUEST WAS MADE. NO OUTCOME WAS REPORTED FOR THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455929 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention