BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2991162 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03379
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V558076, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THERE WAS NO INFECTION ASSOCIATED WITH THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR URGE INCONTINENCE AND RECURRENT URINARY TRACT INFECTIONS. THE PATIENT HAD HER DEVICE REPROGRAMMED TEN MONTHS PRIOR AND NOTED PROGRAMS 3 AND 4 DIDN'T HELP AND WAS CURRENTLY ON PROGRAM 2, WHICH PATIENT FELT WAS NOT HELPING. A VOIDED URINE CULTURE FROM (B)(6) 2012 GREW OUT GREATER THAN 100,000 COLONIES OF E. COLI AND THE PATIENT WAS NOW ON HER SECOND ROUND OF CIPRO. DYSURIA, HESITANCY, AND INCREASED FREQUENCY AND URGENCY WERE ALSO REPORTED. THERE WERE NO FEVERS, CHILLS OR SWEATS. THE PATIENT DID HAVE FLANK OR ABDOMINAL PAIN. IT WAS STATED THAT HER BOWELS WERE MOVING WELL AND THE PATIENT AMBULATED WITH A WALKER. IT WAS NOTED THE PATIENT APPEARED TO BE IN NO ACUTE DISTRESS. IT WAS ALSO STATED THAT THE URGE INCONTINENCE WAS REFRACTORY TO CONSERVATIVE MEDICAL THERAPY AND SACRAL NEUROMODULATION. IT WAS THOUGHT THAT THE PATIENT'S URINARY TRACT INFECTIONS (UTI) WERE CONTRIBUTING TO HER IRRITATIVE VOIDING SYMPTOMS AND URGE INCONTINENCE. IT WAS ALSO REPORTED THAT WHEN THE DEVICE WAS INTERROGATED, THE BATTERY WAS OKAY AND THE IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT HAD TRIED ALL FOUR PROGRAMS AND THEY WERE NOT WORKING. ALL FOUR PROGRAMS WERE REPROGRAMMED ON WEEK PRIOR TO THE REPORT AND THE PATIENT WAS INSTRUCTED TO TRY EACH FOR ONE WEEK AND SEE IF THE DEVICE WAS EFFECTIVE. SIGNS AND SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT WERE INCREASED INCONTINENCE AT NIGHT. NO PATIENT INJURY WAS REPORTED. MORE THAN TWO WEEKS LATER IT WAS STATED THAT ANOTHER REPROGRAMMING HAD BEEN DONE NINE DAYS PRIOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM A HEALTH PROFESSIONAL STATED, THE PATIENT WAS COMPLAINING OF WETTING THE BED AND URINARY LEAKAGE. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED AND THE BATTERY WAS "OKAY" AND IMPEDANCES WERE ALL WITHIN NORMAL LIMITS AFTER INCREASING AMPLITUDE. IT WAS NOTED THAT THE PATIENT SAID PROGRAMS 1 AND 2 "DID NOT WORK AT ALL" AND HAD NOT USED PROGRAMS 3 AND 4. PROGRAMS 1 AND 2 WERE REPROGRAMMED AND THE PATIENT WAS ASKED TO TRY THE PROGRAMS FOR ONE WEEK EACH. THERE WAS A FOLLOW UP APPOINTMENT SCHEDULED FOR (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96242 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention