BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3120689 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07924
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 2, 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: 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 3998 LOT# LA9461, IMPLANTED: 2002 (B)(6), PRODUCT TYPE LEAD (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37712 LOT # NKF701120H, SHOWED NO SIGNIFICANT ANOMALIES AND WAS FUNCTIONALLY OKAY WITH GOOD STABLE OUTPUT SEEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN EXPLANTED AND REPLACED DUE TO ELECTRODES 8 - 15, THE ONLY ELECTRODES CONNECTED, HAVING IMPEDANCES >10,000 OHMS. WHEN IMPEDANCE MEASUREMENT SETTINGS WERE CHANGED TO 1.5 V, IMPEDANCES DROPPED TO 7700 OHMS EXCEPT ELECTRODE 1 WHICH WAS 11,000 OHMS. IT WAS ALSO REPORTED THAT THE TIME BETWEEN RECHARGE SESSIONS DECREASED FROM ROUGHLY EVERY 2 WEEKS WHEN INS WAS FIRST IMPLANTED TO EVERY 2-3 DAYS IN THE YEAR PRIOR TO THE REPORT. PATIENT STATUS AT TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. IT WAS STATED THAT THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. UPON INS REPLACEMENT, IMPEDANCES WERE IN 700-800S OF OHMS. IT WAS STATED THAT THE PATIENT HAD GOOD STIMULATION COVERAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222320 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 Required Intervention