BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3161394 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10120
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 21, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37083-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399930, LOT# V083352, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37083-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 399930, LOT# V083352, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 399930, LOT# V083352, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 399930, LOT# V083352, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. THE INS WAS FUNCTIONALLY OKAY. FINAL DEVICE ANALYSIS OF THE EXTENSIONS REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. THE EXTENSION BODIES WERE CUT THROUGH.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE SITE OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS VERY PAINFUL WHETHER THE DEVICE WAS TURNED ON OR OFF. IT WAS NOTED THAT THE PATIENT FELT THAT THE PAIN AT THE DEVICE SITE OUTWEIGHED THE BENEFIT OF THE THERAPY AND DESIRED TO HAVE IT REMOVED. IN ADDITION, THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S INS AND EXTENSIONS WERE REMOVED DUE TO PAIN AT THE POCKET SITE AND THAT THE PATIENT WAS IN POOR HEALTH (RATED ASA4). PER THE PHYSICIAN, THE PATIENT¿S HEALTH WAS TOO POOR TO RISK REMOVING THE LEADS. NO PATIENT INJURIES WERE REPORTED AND THE OUTCOME FROM THE EVENT WAS NOTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263107 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention