BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3132824 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08266
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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# V621113, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATES THE INFORMATION IN MFR REPORT # 3004209178-2013-10729 PERTAINS TO THIS MANUFACTURER¿S REPORT. ANY ADDIT IONAL INFO WILL BE REPORTED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED IT WAS A NEW ILLNESS OR INJURY INSTEAD OF WORSENING OR EXACERBATION OF A PRE-EXISTING CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PRESENTED WITH ASPIRATION PNEUMONIA. INTERVENTION WAS NOTED AS CEFEPIME 1 GM IV X¿S 1, VANCOMYCIN 2000 MG, Q 18 HRS IV FROM (B)(6) 2013, AZREONAM 1GM IV TID MAY (B)(6) 2013, CEFPODOXIME 200 MG PO BID X¿S 7 DAYS, AND INFECTION DISEASE CONSULTATION (B)(6) 2013, SUSPECT ASPIRATION PNEUMONIA RELATED TO GERD. THE PATIENT SYMPTOMS WERE NOTED AS SHORTNESS OF BREATH AND LIKE AN ELEPHANT WAS SITTING ON THE PATIENT¿S CHEST. CHEST X-RAY IMPRESSION WAS BILATERAL HILAR PERIBRONCHIAL CUFFING LIKELY ASSOCIATED WITH BRONCHITIS, REPORTED DYSPHAGIA AND REGURGITATION. THE PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EDEMA, INCLUDING BILATERAL SWELLING IN THE LOWER EXTREMITIES. AN ULTRASOUND SHOWED NO EVIDENCE OF DEEP VEIN THROMBOSIS (DVT), AND DVT PROPHYLAXIS WAS STARTED. IT WAS REPORTED THAT THE EVENT WAS ONGOING. IT WAS LATER REPORTED THAT THE EVENT WAS CELLULITIS, AND NOT AN EDEMA.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT'S EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237369 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention