BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3790579 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08504
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3 889-28, LOT# VA01ZRB, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AND HAD THEIR WHOLE DEVICE EXPLANTED. IT WAS STATED THE DEVICE WAS KIND OF WORKING FOR THE PATIENT BUT NOT REALLY AND THEY CONTRACTED A (B)(6) INFECTION UPON IMPLANT. IT WAS NOTED THAT EVERYTHING WAS REMOVED INCLUDING THE LEAD AND THE PATIENT THOUGHT IT WAS REMOVED IN (B)(6) 2013. ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THE INFECTION STARTED OR WAS DIAGNOSED IN (B)(6), 2013. IT WAS NOTED THE PATIENT DID NOT HAVE MENINGITIS AND THEY HAD SYMPTOMS OR REDNESS, SWELLING, AND PAIN AT THE DEVICE POCKET. IT WAS REPORTED A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND THE ORGANISM (B)(6) WAS CULTURED. IT WAS STATED THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND THE INFECTION RESOLVED. IT WAS NOTED THE PATIENT HAD A HISTORY OF (B)(6) PRIOR TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269314 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention