BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4681155 · Received April 10, 2015

    Report

    Report Number
    3004209178-2015-07051
    Event Type
    Injury
    Date Received
    April 10, 2015
    Report Date
    March 19, 2015
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37712 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND HAD A REDUCED BATTERY CAPACITY DUE TO OVERDISCHARGE. NO COUPLING OR RECHARGING ISSUES WERE OBSERVED. ANALYSIS OF EXTENSION MODEL 7495 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF EXTENSION MODEL 7495 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF POCKET ADAPTOR MODEL 74002, LOT # N231722, SHOWED NO ANOMALIES. ANALYSIS OF LEAD MODEL 3478A LOT # J0110750V SHOWED NO SIGNIFICANT ANOMALIES. IT WAS NOTED THAT THERE WAS A SHORT DUE TO OVERSTRESS DAMAGE BETWEEN THE #4 AND 7 CIRCUITS, SUSPECTED UNDERNEATH THE #4 CONNECTOR. THE CONTINUITY WAS ACCEPTABLE. ANALYSIS OF LEAD MODEL 3478A LOT # J0110750V SHOWED THAT #2 AND 3 CONDUCTORS WERE BROKEN IN THE BODY OF THE LEAD 13.1 AND 14.4 CM AS MEASURED FROM THE DISTAL END. NO SHORT CIRCUITS WERE OBSERVED. HOWEVER, #2 AND #3 CIRCUITS HAD OPEN CIRCUITS. IT WAS NOTED THAT THE OUTER INSULATION WAS MELTED AND THE BODY OF THE INSULATION WAS CUT THROUGH. ANALYSIS OF THE PLUG/BOOT ACCESSORY MODEL 3550-29 (UNKNOWN LOT#) SHOWED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 74002, LOT# N231722, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 3487A, LOT# J0110750V, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 3487A, LOT# J0110750V, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 3550-29, SERIAL# (B)(4), PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS EXPLANTED DUE TO A LEAD MIGRATION AND DISLODGEMENT. IT WAS ALSO NOTED THAT INS BATTERY DEPLETION WAS NOT NORMAL. THOUGH IT WAS INITIALLY NOTED THAT THE DEVICE WAS NOT REPLACED, FOLLOW UP INFORMATION REPORTED THAT THERE WAS PLACEMENT OF A NEW SPINAL CORD STIMULATOR (SCS) ON (B)(6) 2015. THE PATIENT WAS SEEN ON (B)(6) 2015 WHERE IT WAS NOTED THAT THE SCS DEVICE NEEDED TO BE PROGRAMMED PER PAIN MANAGEMENT . IT WAS ALSO NOTED THAT THE PATIENT¿S INCISIONAL PAIN WAS MINIMAL AND THAT THEY HAD IMPROVED SINCE THE LAST VISIT WITH THE HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE WOUND WAS WELL HEALED WITHOUT SIGNS OF INFECTION, NO ERYTHEMA, TENDERNESS OR DISCHARGE. ADDITIONAL OBSERVATIONS SHOWED THAT THE CRANIAL NERVES WERE NORMAL, THE DTR¿S, MOTOR POWER AND SENSATION NORMAL AND SYMMETRIC. THERE WAS NO PATIENT INJURY REPORTED IN THE EVENT AND THEY WERE NOTED AS RECOVERED WITHOUT SEQUELAE AND DOING ¿GOOD¿. THE PATIENT WAS ALSO NOTED AS PRN WITH THE REPORTING HCP¿S OFFICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238548 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