BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2930999 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01014
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    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
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3093-28, LOT# V013091, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD 'EIGHT BROKEN LEADS.' THE PATIENT SURGERY ON (B)(6) 2013 TO FIX THEM. FOLLOWING THE PROCEDURE THE PATIENT WAS ON PROGRAM 3 AT 4.2V AND RAISED STIMULATION TO 4.3V. IT WAS NOTED THAT THE PATIENT WAS HAVING A HARD TIME SYNCING TO THE INS DUE TO SWELLING AND BANDAGES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD FOUND 'A LOT OF HELP' FROM THE DEVICE OVER THE YEARS, BUT WAS 'REALLY HAVING A PROBLEM' AT THE TIME OF THE REPORT. THE REPORTER STATED THAT THE PATIENT NEEDED TO HAVE SURGERY TO REPLACE THE UNIT OR REPAIR THE LEADS THAT HAD BROKEN, BUT NO SURGERY WAS SCHEDULED. IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTIES SCHEDULING THE SURGERY WITH HER DOCTOR. TWO WEEKS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS A CAR ACCIDENT AND THERE WERE HIGH IMPEDANCES AT REPROGRAMMING ON (B)(6) 2012. SIGNS AND SYMPTOMS OF THE EVENT INCLUDED LOSS OF CLINICAL EFFECT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. NO PATIENT OUTCOME WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING 'SOME FORM OF TRAUMA.' THE REPORTER STATED THAT THE PATIENT HAD 'BROKEN LEADS' THAT NEEDED TO BE 'REATTACHED' TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE REPORTER WAS UNSURE OF WHAT CAUSED THE DAMAGE, BUT MENTIONED THAT THE PATIENT WAS IN A CAR ACCIDENT TWO YEARS PRIOR TO THE REPORT. THE PATIENT HAD A RESURGENCE OF FREQUENCY ISSUES AFTER THAT AND SAW HER HEALTHCARE PROVIDER (HCP) BECAUSE OF THAT. DIAGNOSTIC TESTS WERE PERFORMED AND IT WAS DETERMINED THAT THE ISSUE WAS DAMAGED LEADS. THE REPORTER STATED THAT THE PATIENT WAS SUPPOSED TO HAVE THE LEAD ISSUE TAKEN CARE OF, BUT INSTEAD, THE PATIENT HAD SPENT THE LAST COUPLE OF MONTHS 'IN THE DARK.' IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36408 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention