BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2856362 · Received December 4, 2012

    Report

    Report Number
    3004209178-2012-11112
    Event Type
    Injury
    Date Received
    December 4, 2012
    Report Date
    November 8, 2012
    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

    FINAL ANALYSIS OF THE STIMULATOR REVEALED THE BATTERY HAD REDUCED CAPACITY DUE TO OVER-DISCHARGE. FINAL ANALYSIS OF BOTH LEADS REVEALED THE PROXIMAL END OF THE CONDUCTOR WAS BROKEN. FINAL ANALYSIS OF BOTH EXTENSIONS REVEALED THERE WAS NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 377845 LOT# V011708, IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 377845 LOT# V011708, IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37092 LOT# 239260001, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3708120 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 3708120 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 EXPERIENCED INTERMITTENT STIMULATION AND LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT FELL ON THE BATTERY WHILE WALKING. IT WAS STATED THAT THERE WAS DIAGNOSTIC TESTING AND TROUBLESHOOTING PERFORMED, BUT NO DETAILS WERE GIVEN. THERE WAS A LEAD MIGRATION AND A SUSPECTED OVER DISCHARGED BATTERY. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2012. IT WAS STATED THAT THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. IT WAS ALSO STATED THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. ABOUT ONE WEEK LATER IT WAS CONFIRMED THAT THE BATTERY WAS IN OVER DISCHARGE BECAUSE THE PATIENT HAD NOT USED IT IN SIX MONTHS. THE PATIENT WAS IMPLANTED WITH A NEW LEAD AND BATTERY. IT WAS REPORTED THAT THE PATIENT WAS "DOING WELL" POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00056 YR Required Intervention