BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3232067 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11902
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# VA069BA, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# VA069BA, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS SURGERY. IT WAS NOTED THAT THE EVENT WAS DUE TO THE INS AND THE CAUTERY USED DURING SURGERY. THE PATIENT REPORTEDLY HAD A REVISION. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013. THE REPORTER STATED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THE EVENT AND THE PATIENT OUTCOME WAS NOTED AS ¿NO INJURY.¿ IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN STRUGGLING WITH LOOSE BOWEL SINCE THE EMERGENCY SURGERY TO HAVE PART OF THE INTESTINE REMOVED TWO MONTHS PRIOR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS STATED THAT WHEN THE PATIENT WAS UNABLE TO MAKE AN ADJUSTMENT. THE PATIENT SAW A ¿CALL YOUR DOCTOR ICON¿ AND A POWER-ON-RESET (POR) CONDITION. THE PATIENT HAD EMERGENCY SURGERY 10-11 DAYS AGO, UNRELATED TO THERAPY (INTESTINAL ISSUES). THE HEALTHCARE PROVIDER (HCP) TURNED THERAPY OFF AT THAT TIME. SINCE THEN, THE PATIENT WAS UNABLE TO TURN HIS IMPLANTABLE NEUROSTIMULATOR (INS) BACK ON. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND LOSS OF BOWEL CONTROL. THE PATIENT WAS GOING TO THE BATHROOM EVERY 1 TO 1.5 HOURS. THE PATIENT SPOKE WITH HIS HCP ON (B)(6) 2013 AND THE SOONEST THE PATIENT COULD BE SEEN BY THE MANUFACTURER REPRESENTATIVE WOULD BE (B)(6) 2013. THE PATIENT REPORTEDLY COULD NOT WAIT THAT LONG. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TWO PROGRAMS AND WAS ON PROGRAM ONE IN THE PAST. THE PATIENT RECEIVED MORE CONTROL ON PROGRAM TWO. THE PATIENT REPORTEDLY SWITCHED TO PROGRAM TWO LAST WEEK. ON PROGRAM ONE, THE PATIENT EXPERIENCED TINGLING IN HIS TESTICLE WHEN STIMULATION WAS TURNED UP ENOUGH TO GET CONTROL. THE TINGLING WAS UNDESIRABLE. IT WAS STATED THAT OVER THE PAST TWO DAYS, THE PATIENT FELT THE CONSTANT NEED TO GO TO THE BATHROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332150 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention