BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4614204 · Received March 18, 2015

    Report

    Report Number
    3004209178-2015-04986
    Event Type
    Injury
    Date Received
    March 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Removal / Correction Number
    Z-0500-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN, SERIAL# UNKNOWN, PRODUCT TYPE: UNKNOWN; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3550-39, LOT# N202076, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (SN (B)(4)) FOUND THAT THE LEAD BODY CONDUCTOR WAS BROKEN AT THE ANCHOR SITE, UNKNOWN. ALL WIRES WERE BROKEN 19.5 CENTIMETERS FROM THE DISTAL END. ANALYSIS OF THE LEAD (SN (B)(4)) FOUND THAT THE LEAD BODY CONDUCTOR WAS BROKEN AT THE ANCHOR SITE, UNKNOWN. ALL WIRES WERE BROKEN 19.4 CENTIMETERS FROM THE DISTAL END. ANALYSIS OF THE ANCHOR (SN (B)(4)) FOUND THAT THE ANCHOR TITAN ANCHOR SEPARATED. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SN (B)(4)) FOUND THAT THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS AFTER PHYSICIAN MODE RECHARGE (PMR) RECOVERY, THE TOTAL RECHARGE COUNT WAS 366. THE LAST RECORDED RECHARGE SESSION PERFORMED WHILE THE DEVICE WAS IMPLANTED OCCURRED ON (B)(6) 2011. THE DEVICE WAS RECHARGED FOR 3HOURS 11MINUTES AND THE BATTERY CHARGED FROM 3.735VOLTS TO 4.020 VOLTS. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2012. THE LAST PATIENT USAGE WAS ON (B)(6) 2012. A NORMAL RECHARGE WAS STARTED MANUALLY AFTER TWO PHYSICIAN MODE RECHARGES. DUE TO RAPID DISCHARGE; THREE CHARGE SESSIONS OCCURRED BEFORE OBTAINING THE INITIAL REVIEW AND TRACE REPORT. DURING THE FINAL CHARGE THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 22MINUTES FROM 3.505 VOLTS TO 3.790 VOLTS. (B)(4).

    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 ONE ANCHOR CAME APART AND THE INSIDE TITANIUM PART WAS SCARRED IN THE GENERATOR POCKET. THE PHYSICIAN PULLED THE LEADS FREE FROM THE POCKET AND THE OTHER PART OF THAT ANCHOR AND THE OTHER LEAD ANCHOR WERE LEFT INSIDE THE PATIENT. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT HAD STOPPED USING THE STIMULATION THERAPY SINCE HER RSD HAD GOTTEN BETTER AND SHE NO LONGER NEEDED IT. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183960 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