BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2747087 · Received September 17, 2012

    Report

    Report Number
    3004209178-2012-08176
    Event Type
    Injury
    Date Received
    September 17, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4), LOT# V517659, SERIAL#, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID (B)(4), LOT#, SERIAL# (B)(4), IMPLANTED:, EXPLANTED:, PRODUCT TYPE: PROGRAMMER, PATIENT; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SLIGHT DISCOMFORT IF SHE WALKS TOO FAST OR SITTING IN A CHAIR TOO LONG, OTHERWISE THE THERAPY WAS WORKING WELL FOR HER. THE PATIENT STATED THAT HER "SYMPTOMS ARE ALL BUT GONE." THE PATIENT HAD SHARP PAIN AT INS POCKET AT TIMES BUT THE PATIENT WANTED TO KNOW IF FOLLOW UP WITH HER HEALTH CARE PROVIDER COULD WAIT UNTIL SHE GOT BACK FROM A TRIP OVERSEAS. THE PATIENT HAD REPROGRAMMING ON (B)(6) 2012. THE PATIENT HAD DEVICES EXPLANTED. THE CAUSE OF THIS EVENT WAS INFECTION. THE PATIENT EXPERIENCED INTERMITTENT DRAINAGE FROM INCISION. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE RE-IMPLANT WAS PLANNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention