BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2251604 · Received September 14, 2011

    Report

    Report Number
    3004209178-2011-07865
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STARTED HAVING TO GO TO THE RESTROOM MORE FREQUENTLY AT NIGHT SOMETIME IN THE MIDDLE OF AUGUST. THE PT FELT THE DEVICE WAS WORKING BECAUSE SHE KNEW SHE HAD TO GO TO HE BATHROOM AND WAS NOT LEAKING. THE PT STATED THAT WHEN SHE DID GET UP DURING THE NIGHT SHE WAS ABLE TO URINATE. SHE DID NOT CATHETERIZE HERSELF. THE PT FELT THE STIMULATOR WAS WORKING, BUT GOT BETTER SYMPTOM RELIEF BEFORE (B)(6) 2011 WHEN THE FREQUENCY ISSUES STARTED. IT ALSO REPORTED THAT THE PT STRUGGLED WITH URINARY TRACT INFECTIONS PRIOR TO IMPLANT AND POST IMPLANT, BUT HAD A CLEAN CULTURE IN (B)(6). HE PT HAD A SONOGRAM OF HER BLADDER SOMETIME IN THE FEW WEEKS PRECEDING (B)(6) 2011 AND "THAT WAS OK." THE PT HAD A (B)(4) STUDY DONE WHICH DETERMINED SHE WAS ONLY EMPTYING HALF HER BLADDER. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V436021| PROGRAMMER: MODEL 3037, LOT#NJD102700N| PROGRAMMER: MODEL 3037, LOT#NJD102700N| LEAD: MODEL 3889, LOT# V436021| EXPLANTED:| IMPLANTED: