BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3689185 · Received March 19, 2014

    Report

    Report Number
    3004209178-2014-04679
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALY. THE STIMULATOR WAS FUNCTIONAL OKAY. FINAL ANALYSIS OF THE LEAD ((B)(4)) REVEALED NO SIGNIFICANT ANOMALY. THE DISTAL END OF THE LEAD WAS STRETCHED. FINAL ANALYSIS OF THE LEAD ((B)(4)) REVEALED NO SIGNIFICANT ANOMALY. THE LEAD BODY OUTER INSULATION WAS MELTED. FINAL ANALYSIS OF THE EXTENSION REVEALED NO SIGNIFICANT ANOMALY. THE EXTENSION BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A-45, LOT# V230726, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3487A-45, LOT# V230726, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. 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

    (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 THE PATIENT DID NOT HAVE ANY RELIEF. IT WAS NOTED THEY HAD A LOSS OF PAIN RELIEF. IT WAS NOTED THE DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT'S STIMULATOR WAS EXPLANTED BECAUSE THE PATIENT'S PAIN IMPROVED AND THE STIMULATOR WAS NO LONGER NECESSARY. THE PATIENT WAS NOT RE-IMPLANTED AND THEY WERE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162941 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention