BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3190271 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10891
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    February 1, 2013
    Report Date
    September 29, 2017
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V718508, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3037 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    NOTE THAT SECTION INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28 LOT# V718508 IMPLANTED: (B)(6)2011 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3095-10 (B)(4) IMPLANTED: (B)(6)2011 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3037 (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28 LOT# V718508 IMPLANTED:(B)(6) 2011-07 PRODUCT TYPE LEAD PRODUCT ID 3095-10 SERIAL(B)(4) IMPLANTED: (B)(6)2011 PRODUCT TYPE EXTENSION PRODUCT ID 3037 SERIAL(B)(4) PRODUCT TYPE PROGRAMMER, PATIENT IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 DEVICE WAS MORE ¿MOBILE¿ UNDER THE SKIN DUE TO THE PATIENT¿S WEIGHT LOSS. THE DEVICE WAS ¿SHIFTING¿ UNDER THE SKIN. THE SEVERITY OF THE EVENT WAS LISTED AS MILD. NO INTERVENTIONS WERE NOTED. THE OUTCOME OF THE EVENT WAS INDICATED AS ¿ONGOING¿ WITH NO FURTHER ACTION NEEDED. INFORMATION RECEIVED THREE DAYS LATER INDICATED THAT THE DEVICE WAS ¿VISIBLY MOBILE¿ WITH PALPITATION. THIS WAS NOTED ON 2013 (B)(6). ABOUT TEN DAYS LATER, IT WAS STATED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY, BUT NOT RELATED TO THE IMPLANT PROCEDURE. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON 2017-JUN-08 UPDATED THE OUTCOME TO DEATH AND THEN ON 2017-JUN-09 UPDATED THE OUTCOME FROM DEATH TO RESOLVED WITHOUT SEQUELA ON (B)(6)2015. FURTHER INFORMATION RECEIVED ON 2017-JUN-17 INDICATE DEVICE HYPERMOBILITY IN POCKET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS DEVICE MOBILITY IN THE POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291365 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR