BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2948228 · Received February 7, 2013

    Report

    Report Number
    3004209178-2013-01419
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3998 LOT# V077531V01, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-45 LOT# V780541, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-33 LOT# V340247, IMPLANTED: 2009 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS), LEADS, AND EXTENSIONS WERE EXPLANTED DUE TO INFECTION. NONE OF THE DEVICES WILL BE RETURNED. CULTURES WERE TAKEN FROM DEVICE POCKET AND LEAD SITE. IT WAS STATED THAT THE PATIENT WAS SCHEDULED FOR REVISION OF A LEAD, AND DURING THE OPERATION, INFECTIOUS DRAINAGE WAS NOTICED AT THE LEAD SITE AND STIMULATOR POCKET. IT WAS STATED THAT ANTIBIOTIC IRRIGATION WAS USED AT EACH WOUND SITE PRIOR TO CLOSURE. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY OTHER SIGNS OR SYMPTOMS OF INFECTION PRIOR TO VISUAL INSPECTION OF INCISION SITES. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52101 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention