BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3233875 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11971
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    April 14, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V779499, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD MEDICAL OR NON-SURGICAL THERAPY. IT WAS NOTED THEY WERE GIVEN CIPRO ANTIBIOTIC FOR 10 DAYS. IT WAS STATED THE PATIENT HAD FREQUENCY, BURNING, AND PAIN. IT WAS STATED THE PATIENT RESOLVED WITHOUT SEQUELAE ON 2013-(B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, (B)(4): IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY RETENTION. IT WAS STATED THAT THIS WAS A WORSENING OR EXACERBATION OF A PRE-EXISTING CONDITION. IT WAS STATED THAT A CYSTOSCOPY WAS PERFORMED. THE PATIENT WAS TREATED WITH PERCOCET, DEMEROL, AND PHENERGAN ON (B)(6) 2013. THE PATIENT HAD A RESIDUAL BLADDER VOLUME OF 300CC POST VOID.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM A HEALTHCARE PROVIDER FOR A CLINICAL STUDY REPORTED THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CHANGED THE OUTCOME FROM RESOLVED WITHOUT SEQUELAE TO AN ONGOING EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE ETIOLOGY WAS A NEW ILLNESS, INJURY INSTEAD OF PRE-EXISTING CONDITION WORSENING OR EXACERBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333229 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention