BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3790195 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08499
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V533702, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFECTION WAS NOTED. THE PATIENT HAD BEEN HAVING URINARY TRACT INFECTIONS OVER THE LAST THREE YEARS. THE PATIENT'S FORMER DOCTOR HAD HER ON A CONSTANT DOSE OF PENICILLIN. THE PATIENT CHANGED HCPS (HEALTHCARE PROVIDER) AND HER NEW DOCTOR DIDN'T WANT HER ON IT. THE PATIENT WANTED TO KNOW IF THE INTERSTIM COULD BE THE CAUSE. IT WAS ALSO NOTED THAT THE PATIENT SAW SOMETHING ON TV ABOUT A RECALL INVOLVING INS/LEAD MOVEMENT AND INFECTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS HISTORY OF RECURRENT UTIS. REGARDING SIGNS AND SYMPTOMS IT WAS NOTED THE PATIENT HAD RECURRENT UTI'S, CHRONIC BACTERIA, USUALLY ASYMPTOMATIC. HOSPITALIZATION WAS NOT REQUIRED. PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267168 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention