BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3070712 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06631
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 2, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN STATED, THE PATIENT EXPERIENCED "POCKET EROSION" AND AN INFECTION PRIMARILY LOCATED AT THEIR "DEVICE POCKET." IT WAS REPORTED THAT A CULTURE WAS NOT OBTAINED AND THAT PERIOPERATIVE ANTIBIOTICS WERE NOT ADMINISTERED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE MENINGITIS. IT WAS REPORTED THE PATIENT'S OUTCOME FOLLOWING "TOTAL DEVICE SYSTEM EXPLANT" WAS "INFECTION RESOLVED." IT WAS ALSO NOTED THE PATIENT HAD A "DEBILITATED STATUS" PRIOR TO DEVICE IMPLANTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS EROSION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. BOTH THE LEAD AND INS WERE EXPLANTED. THE ONSET OF THIS EVENT WAS UNKNOWN. A LITTLE MORE THAN A WEEK LATER, IT WAS STATED THE EXPLANT "WENT WELL." AN INFECTION WAS ALSO FOUND AT THE INS SITE. THE PATIENT WAS TO BE REVIEWED GOING FORTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171979 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention