BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2905411 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00391
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V449145, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY THEIR PHYSICIAN IN (B)(6) 2013 FOR THE DEHYDRATION ISSUE. THE PHYSICIAN COULD NOT RULE OUT THE ISSUE WAS RELATED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT DUE THIS, THE SYSTEM WAS EXPLANTED. THE EXPLANTED COMPONENTS WERE THEN SENT TO THE PATHOLOGY DEPARTMENT AND IT WAS UNKNOWN IT THEY WERE TO BE RETURNED TO THE MANUFACTURE FOR ANALYSIS. IT WAS NOTED THAT THE PATHOLOGY REPORT DID NOT SHOW "ANYTHING OUT OF THE ORDINARY". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS STATED THAT THE PATIENT WAS WORKING WITH THEIR HEALTH CARE PROVIDER TO RESOLVE THE ISSUE. THE PATIENT HAD AN APPOINTMENT WITH A NEW DOCTOR SCHEDULED FOR (B)(6)-2013. IT WAS ALSO STATED THAT THE PATIENT HAD NOT SOUGHT FURTHER HELP WITH THEIR DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR DEHYDRATION. IT WAS STATED THE PATIENT HAD SUFFERED FROM DEHYDRATION RELATED TO THEIR BLADDER ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11645 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R