BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3841386 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09928
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V671773, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED SLIGHT PAIN NEAR THE TAILBONE AND HAD A LOW GRADE TEMPERATURE. THERE WAS NO EVIDENCE OF INFECTION AND THERE WERE MILD LAB ABNORMALITIES. THE SACRAL PAIN WAS RELATED TO THE LEAD. RIFAMPIN AND DOXYCYCLINE WERE GIVEN PROPHYLACTICALLY DUE TO A HISTORY OF INFECTION. THE EVENT WAS REPORTED TO BE ONGOING. IT WAS STATED THE CT SCAN SHOWED MILD DEGENERATIVE DISK DISEASE IN THE MID-LOWER LUMBAR SPINE. CYCLING WAS ALSO TURNED ON THE PATIENT¿S CURRENT PROGRAM. THE PATIENT WAS ADVISED TO TURN OFF THE DEVICE FOR A FEW DAYS TO DETERMINE IF THE PAIN RESOLVED. A CT SCAN WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GIVEN A LIDODERM PATCH 5%. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS NOT AS PAINFUL AFTER REPROGRAMMING THAT OCCURRED ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT STIMULATION WAS NOT AS PAINFUL AFTER REPROGRAMMING. ADDITIONAL INFORMATION RECEIVED INDICATED PROGRAMS 3 AND 4 WERE ADDED. ADDITIONAL INFORMATION REPORTED THE LEAD AND STIMULATOR WERE REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317955 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention