BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3843280 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09958
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 12, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD (B)(4) FOUND ALL CONDUCTORS WERE BROKEN 14.4 CM FROM THE DISTAL END. ANALYSIS OF THE LEAD (B)(4) FOUND CONDUCTORS #0, #3-#7 WERE BROKEN 21.0 CM FROM THE DISTAL END. ANALYSIS OF THE ANCHORS FOUND NO SIGNIFICANT ANOMALY, THE ANCHORS WERE SEATED ON THE EXPLANTED LEADS.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD LOSS OF STIMULATION AND LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT HAD LESS THAN 50% THERAPY RELIEF AT THE LEAD LOCATION. IT WAS REPORTED THAT IMPEDANCE TESTING, X-RAYS AND REPROGRAMMING HAD BEEN PERFORMED. IT WAS STATED THAT THE ISSUE WAS NOT RESOLVED, AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED ON THE DAY OF THIS REPORT. IT WAS REPORTED THAT THE PATIENT WOULD HAVE A REVISION AT A LATER DATE. IT WAS STATED THAT THE DEVICE WAS CURRENTLY IMPLANTED AND REMAINED IN SERVICE. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL IMPEDANCES HAD BEEN >10,000 OHMS. IT WAS REPORTED THAT THE X-RAY SHOWED THE LEAD HAD MOVED UP. IT WAS NOTED THAT THERE WAS NO CHANGE WITH REPROGRAMMING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WOULD GET THEIR SYSTEM REVISED ¿AT SOME POINT¿ BUT IT HAD NOT BEEN SCHEDULED YET. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LEAD REVISION. IT WAS REPORTED THAT BOTH OLD LEADS WERE TAKEN OUT AND 2 NEW LEADS WERE IMPLANTED. IT WAS REPORTED THAT IMPEDANCES WERE ¿GOOD NOW¿. IT WAS STATED THAT THE PATIENT GOT COVERAGE WHERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321402 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention