BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4871349 · Received June 26, 2015

    Report

    Report Number
    3007566237-2015-01774
    Event Type
    Injury
    Date Received
    June 26, 2015
    Report Date
    May 18, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA09VZ3, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS #3007566237. ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING SITE ID IS #3004209178.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A POCKET REVISION IN THE PAST COUPLE OF WEEKS. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR REVISION WAS THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED CLOSER TO THE SURFACE OF THE SKIN DUE TO POSSIBLE WEIGHT CHANGES. THE REPORTER WAS NOT AWARE OF THE PATIENT HAVING ANY PHYSICAL SYMPTOMS. THE REVISION WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415406 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention