BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2980712 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03109
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 5, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR RESULTED IN NO ANOMALIES FOUND, THE SETSCREWS WERE TIGHT AND IN THE CORRECT LOCATION OF THE EXTENSIONS. ANALYSIS OF THE EXTENSIONS RESULTED IN NO SIGNIFICANT ANOMALIES FOUND, THE BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED. THEY WERE CUT TOO SHORT TO PERFORM A SYSTEM TEST. IN ADDITION, ON EXTENSION (SN (B)(4)) THE OUTER INSULATION WAS SEVERELY PINCHED AND TORN, THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING AROUND THAT AREA. ANALYSIS OF THE LEADS RESULTED IN NO SIGNIFICANT ANOMALIES FOUND, THE LEAD BODY WAS CUT THROUGH AND THE PRODUCT WAS SEGMENTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3987A60, LOT# N130554, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3987A60, LOT# N130554, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3587A. PRODUCT TYPE: LEAD. (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

    (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 THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED PER THE PATIENT'S REQUEST. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD EXPERIENCED "IRRITATION." THE PATIENT WAS REPORTED TO HAVE "RECOVERED WITHOUT SEQUELAE." A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84483 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