BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3032482 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04520
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED REASONABLY SUGGESTED THE "RIGHT" SIDED DEVICE CORRESPONDED TO THE SERIAL NUMBER REPORTED ON THIS REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3058 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID, 3889-33 LOT# VA027ML, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3889-33 LOT# VA027ML, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR HEALTHCARE PROVIDER AND THEIR CONCERNS WERE RESOLVED. IT WAS STATED THE "RIGHT" UNIT WAS REMOVED. ABOUT TEN DAYS LATER, IT WAS REPORTED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE PATIENT'S SYMPTOMS INCLUDED, FEVER, REDNESS, SWELLING, DRAINAGE, AND PAIN. THE ORGANISM CULTURED AT THE DEVICE POCKET WAS A STAPH AUREUS. ORAL ANTIBIOTICS WERE GIVEN AND THE PATIENT OUTCOME WAS LISTED AS "ONGOING." IT WAS NOTED THE PATIENT HAD DIABETES AS WELL, WHICH WAS CONSIDERED A RISK FACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE WAS "INFLAMED, SORE, AND WARM TO THE TOUCH." IT WAS LATER REPORTED FROM THE PATIENT HAD AN INFECTION. IT WAS STATED THAT AN INCISION AND DRAINAGE OF RIGHT POCKET WAS PERFORMED APPROXIMATELY ON (B)(6) 2013. IT WAS NOTED THAT THERE WERE NO HOSPITALIZATIONS. THE HEALTHCARE PROVIDER REPORTEDLY PLANNED TO REMOVE THE RIGHT INS. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136334 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention