BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2800423 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09417
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V625723 SERIAL#, IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD; PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT 2012 (B)(4), TYPE PROGRAMMER, PATIENT; (B)(4). ANALYSIS OF LEAD FOUND THAT THE LEAD BODY HAD BROKEN CONDUCTORS AT OR NEAR TINES.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V625723, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). NO DEVICE RETURNED, AND NO ANALYSIS HAS BEEN COMPLETED. NO INTERVENTION REQUIRED OR SERIOUS INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT FOR THE LAST "COUPLE OF MONTHS" WITHOUT A RELATED, KNOWN ACCIDENT OR INCIDENT. THE PATIENT COULD NOT TURN STIMULATION UP ANY HIGHER, SO THE NURSE CHANGED PROGRAMS AND INCREASED STIMULATION UNTIL THE PATIENT FELT IT. THE PATIENT FELT STIMULATION AT 6.4 VOLTS, BUT "IT QUICKLY FADED AWAY." THE PATIENT FELT STIMULATION IN THE APPROPRIATE LOCATION WITH A STEADY PULSE AT 7.8 VOLTS. PATIENT WAS GOING TO MONITOR SYMPTOM RELIEF. TWO AND A HALF MONTHS LATER, ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LEAD WAS REPLACED. THE IMPEDANCES WERE OUT OF RANGE AND THE PATIENT DID NOT FEEL STIMULATION. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS FURTHER NOTED THAT THE PATIENT NEVER HAD A LEAD REPLACEMENT. MFR. REP. # 3004209178-2012-09498 IS FOR A SEPARATE PATIENT AND IS NO WAY RELATED TO THIS REPORT.

    Description of Event or Problem · 1

    REVIEW OF INFORMATION RECEIVED DETERMINED THE EVENT PREVIOUSLY REPORTED REGARDING THE LEAD REPLACEMENT THAT OCCURRED WAS A SEPARATE EVENT, AND WAS ALSO REPORTED UNDER MFR. REP. # 3004209178-2012-09498. ALL FUTURE FOLLOW UP REGARDING THE LEAD REPLACEMENT WILL BE CONDUCTED UNDER MFR. REP. #3004209178-2012-09498 WHILE FUTURE FOLLOW UP REGARDING EVENT WHERE PATIENT ADJUSTED STIMULATION TO A STEADY PULSE WILL BE CONDUCTED UNDER THIS MFR. REP. #3004209178-2012-09417.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention