BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4090189 · Received September 15, 2014

    Report

    Report Number
    3004209178-2014-17037
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# VA0E9EK, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A POSSIBLE INFECTION, BUT IT WAS MOST LIKELY CLOSE TO EROSION ONLY. THE IMPLANT WAS CLOSE TO THE SKIN BUT HADN¿T GONE THROUGH THE ORIGINAL IMPLANT SITE AND THE EVENT TOOK PLACE AROUND (B)(6) 2014. THE HEALTH CARE PROVIDER (HCP) WAS CULTURING THE POCKET TISSUE AND MADE A DEEPER POCKET. THE ACTIONS REQUIRED AS A RESULT OF THE EVENT WAS A REVISION WHERE A DEEPER POCKET WAS MADE AND ALL HARDWARE ¿ENTRANCE AND FUNCTIONING.¿ DIAGNOSTIC TESTING OF IMPEDANCE TESTING WAS PERFORMED. THE PRODUCT ISSUE WAS RESOLVED AND IT WAS UNKNOWN IF THE CAUSE OF THE ISSUE WAS DETERMINED. THE PATIENT STATUS WAS ALIVE WITH NO INJURY AND THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED AND REMAINED IN SERVICE. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED AND THERE WAS NO DIAGNOSIS OF INFECTION IT WAS JUST POSSIBLE UNTIL THE CULTURES CAME BACK. THE HCP NOTICED THE POSSIBLE INFECTION ON A FOLLOW-UP APPOINTMENT. THE PATIENT DID NOT HAVE MENINGITIS AND THE SIGNS AND SYMPTOMS OF THE INFECTION WAS RED INFLAMED TISSUE AT THE POCKET SITE. THE PRIMARY LOCATION OF THE INFECTION WAS AT THE INCISION AND THE CULTURE SOURCE WAS AT THE INCISION AND ALSO SWABBED AT THE POCKET. IT WAS UNKNOWN WHAT TYPE OF ORGANISM WAS CULTURED YET AND THE PATIENT WAS FINE. IT WOULD NOT BE KNOWN IF THE INFECTION HAD RESOLVED UNTIL THEY KNEW IF IT WAS INFECTED. THEY WOULD FINE OUT THE RESULTS OF THE CULTURE IN 5 DAYS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT铠BACK WAS HEALING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DOING WELL. THERE WAS NO ONGOING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568553 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention