BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4723702 · Received April 23, 2015

    Report

    Report Number
    3004209178-2015-07770
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 377760, LOT# V004735, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V003346, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SPOT ON THEIR STIMULATOR SITE THAT WAS NOT HEALING AND NEEDED SURGERY TO CLOSE THE INCISION AS SOON AS POSSIBLE. A POCKET REVISION WAS PLANNED BUT ONCE IN SURGERY THE WOUND WAS NOT GOING TO HEAL PROPERLY SO THE PHYSICIAN DECIDED TO EXPLANT THE ENTIRE SYSTEM. THERE WAS DRAINAGE/INCISIONAL WOUND OPENING ALONG WITH EROSION ON THE DEVICE POCKET OF THE RIGHT SIDE IMPLANT. IF ADDITIONAL INFORMATION IS RECEIVED ON OUTCOME A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270865 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention