BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4795628 · Received May 26, 2015

    Report

    Report Number
    3007566237-2015-01429
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 PRODUCT: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # VA0TNX9, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    REPORTER WAS IN CASE WITH IMPLANTABLE NEUROSTIMULATOR AND REPORTED READING >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. IT WAS REPORTED THAT THEY HAVE REMOVED; DRIED OFF AND REPLACED LEAD A COUPLE TIMES. IMPEDANCES THAT WERE ABNORMAL WERE AS FOLLOWS: C1 >4000, 01 >4000, 02 3864, 03 2426, 12 >4000, 13 >4000 AND 23 3864. IT WAS TESTED >4000 COMBINATIONS AND THEY DIDN'T PRODUCE MOTOR RESPONSE AT 5 V. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER INDICATED THAT THE IMPEDANCE ISSUES RESOLVED BEFORE THE PHYSICIAN CLOSED THE POCKET. THE CAUSE OF THE IMPEDANCE ISSUE WAS NOT DETERMINED AND WAS NOTED AS NOT DEVICE RELATED. THERE WAS NO LEAD FRACTURE(S) NOTED. THERE WAS MULTIPLE TROUBLE SHOOTING STRATEGIES, INCLUDING RUNNING IMPEDANCE CHECKS AT VARIOUS RATES, DISCONNECTING AND RECONNECTING THE LEAD AND CLEANING THE LEAD. THEY REPLACED INITIAL LEAD, WITH CLEAN IMPEDANCE CHECK. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339297 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention