BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2380531 · Received December 19, 2011

    Report

    Report Number
    3004209178-2011-09891
    Event Type
    Injury
    Date Received
    December 19, 2011
    Report Date
    December 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER MODEL 3037, (B)(4), IMPLANTED: NA, EXPLANTED: NA, LEAD MODEL 3889, LOT # V103841, IMPLANTED: (B)(4) 2008, EXPLANTED: UNK. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ONGOING URINARY INFECTION OCCURRED FOR THE LAST 3 YEARS. ADDITIONALLY, THERE WAS NO STIMULATION SENSATION FOLLOWING A FALL. THE FALL WAS RECENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPERIENCED "OFF AND ON" RELIEF SINCE IMPLANTATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. HER FALL WAS REPORTED AS HAVING OCCURRED A YEAR AGO AFTER WHICH SHE NO LONGER FELT HER STIMULATION. THE PATIENT HAD RELOCATED AND WAS SEEKING A NEW PHYSICIAN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention