BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3082100 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06982
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 10, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V560419, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V560419, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V560419, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT #V560419, FOUND ALL CONDUCTORS BROKEN IN THE TINES AREA 4 CM FORM THE DISTAL END OF THE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT BEGAN TO EXPERIENCE "SPORADIC" SHOCKING IN THEIR LOWER RECTUM THE PREVIOUS WEEKEND. IT WAS NOTED THAT IT DID NOT APPEAR THE SHOCKING WAS RELATED TO A SPECIFIC BODY POSITION. NO KNOWN ACCIDENTS OR INCIDENTS WERE REPORTED IN RELATION TO THE SHOCKING. IMPEDANCES WERE MEASURED AND THEY WERE REPORTED AS "NORMAL." IT WAS INDICATED THAT THE THERAPY WAS "WORKING WELL" FOR THE PATIENT'S SYMPTOMS, DESPITE THE SHOCKING. THE PATIENT WAS REPROGRAMMED AS OF THE DATE OF THIS REPORT. ABOUT A WEEK LATER, IT WAS INDICATED THE PATIENT FELT THE SHOCKING IN THEIR VAGINA AREA AND IT WAS "VERY PAINFUL." THE PATIENT WOULD HAVE TO SIT DOWN WHEN IT OCCURRED. IT WAS ADDITIONALLY STATED THE PATIENT HAD BARIATRIC SURGERY AND THE POCKET WAS OPENED TO REMOVE EXTRA TISSUE. THE DATE OF THE SURGERY WAS UNKNOWN. IN ADDITION, HIGH IMPEDANCES WERE MEASURED. MEASUREMENTS OF GREATER THAN 4,000 OHMS WERE REPORTED ON "SOME" OF THE BIPOLAR PAIRS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPEDANCE TOTALS SHOWED DAMAGED ELECTRODES. THE LEAD SHOWED GREATER THAN 4,000 OHMS ON ALL ELECTRODE COMBINATIONS AND LEAD BREAKAGE WAS NOTED. THE PATIENT STATED THAT SHE DID NOT FALL. THERE WAS NO PATIENT INJURY OR DEATH AND SHE RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT HIGH IMPEDANCES (>40,000 OHMS) WERE SEEN ON SOME THE ELECTRODE COMBINATIONS. THE PATIENT WAS SCHEDULE FOR A LEAD REPLACEMENT SURGERY FOR (B)(6) 2013. ADDITIONAL FOLLOW UP INFORMATION RECEIVED 10 DAYS CONFIRMED THAT THE PHYSICIAN REPLACED THE LEAD. FOLLOWING THE SURGERY, THE PATIENT FELT NORMAL STIMULATION WITH NO SHOCKING.

    Description of Event or Problem · 1

    IT WAS NOTED THAT AFTER THE BARIATRIC SURGERY THE PATIENT'S POCKET BECAME VERY LOOSE AND THE SURGEON HAD TO RE-OPEN AND RECLOSE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183855 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention