BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3190402 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10899
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 4, 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

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3708140, LOT# SERIAL# (B)(6), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS AND EXTENSIONS HAD HIGH IMPEDANCES AND WERE REPLACED. IT WAS NOTED THE LEADS HAD AN IMPEDANCE VALUE GREATER THAN 10 ,000 ON ALL ELECTRODES AND WERE REPLACED ALONG WITH THE EXTENSION ON (B)(6)-2013. IT WAS FURTHER NOTED PATIENT HAD A LOSS OF THERAPY. IT WAS NOTED THE PATIENT STATUS WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. IT WAS REPORTED THAT AFTER THE LEADS AND EXTENSION WERE REPLACED, THE PATIENT HAD A RETURN OF THERAPY AND HAD GOOD PAIN CONTROL.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT IT WAS BELIEVED THAT THE HIGH IMPEDANCES WERE DUE TO AN OPEN CIRCUIT WITHIN THE LEAD/EXTENSION C OMPONENTS DUE TO THE TOTAL LOSS OF THERAPEUTIC EFFECT THE PATIENT EXPERIENCED. THE PHYSICIAN DETERMINED THAT BOTH THE LEADS AND EXTENSIONS SHOULD BE REPLACED TO MAKE SURE THE DEVICE SYSTEM INTEGRITY WAS INTACT FOR A LONG TIME INTO THE FUTURE. IT WAS ALSO NOTED THAT THE PATIENT DID NOT FEEL ANY STIMULATION AT ANY AMPLITUDE DURING THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291179 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 Required Intervention