BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3013272 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03985
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 17, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THE LEAD INCISION SITE. THE PATIENT HAD A YELLOW DRAINAGE FROM THE LEAD INCISION SITE. ANTIBIOTICS WERE ADMINISTERED, AND THE LEADS WERE PLANNED TO BE REMOVED. DATE OF ONSET/DIAGNOSIS WAS REPORTED AS (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THE LEADS REMOVED DUE TO THE INFECTION AT THE SPINAL INCISION SITE. THE PATIENT WAS TREATED WITH 2 ROUNDS OF ANTIBIOTICS PRIOR TO LEAD EXPLANT. THE IMPLANTABLE NEUROSTIMULATOR (INS) REMAINED IMPLANTED FOR PLANNED FUTURE REPLACEMENT OF LEADS. THE PATIENT'S STATUS AT TIME OF REPORT WAS NOTED AS NO INJURY/NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115821 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 00047 YR Required Intervention