BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3052035 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-05988
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 22, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S LEADS WERE CUT DURING THE PATIENT¿S SPINAL FUSION SURGERY IN (B)(6) 2012 FOLLOWING HER CAR ACCIDENT. IT WAS NOTED THE PATIENT HAD BEEN USING STIMULATION UP UNTIL HER LEADS WERE FIXED IN (B)(6) 2013. THE PATIENT WAS NOW USING STIMULATION AND IT WAS WORKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A REVISION OF THE LEAD COMPONENT OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS) DONE TODAY DUE TO HIGH IMPEDANCES. IT WAS NOTED THAT THE PATIENT WAS IN A CAR ACCIDENT 2 YEARS AGO AND HAD A SURGERY LAST YEAR BUT DID NOT HAVE ANY FALLS. FOLLOW UP INFORMATION INDICATED THAT NOTHING FURTHER HAD BEEN HEARD FROM THE PATIENT OR PHYSICIAN REGARDING THE PLANNED REVISION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BOTH LEADS REPLACED ON (B)(6) 2013. IT WAS NOTED UNDER FLUOROSCOPY THE DOCTOR COULD SEE "WHAT APPEARED TO BE A COMPLETE FRACTURE OF THE LEADS." WHEN THE LEADS WERE REMOVED IT WAS NOTED THE "POLY COATING ON THE LEAD WAS INTACT SO THE FRACTURES MUST HAVE BEEN THE WIRES INSIDE." THE NEW LEADS WERE ATTACHED TO THE PATIENT'S EXISTING BATTERY AND ALL IMPEDANCES WERE WITHIN NORMAL RANGE. THE PATIENT WAS GETTING "GOOD" STIMULATION COVERAGE IN THE PACU (POST-ANESTHESIA CARE UNIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155328 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention