BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2980724 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03111
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF PROGRAMMER MODEL # 3037 (LOT # NJD128933N) SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: #REVIEWED AND CONFIRMED / UPDATED RFR, HAZARD, CAUSE AND PSC CODES. A GOOD FAITH EFFORT FOR FOLLOW-UP WAS CONDUCTED BUT THE INFORMATION PROVIDED IS INSUFFICIENT BECAUSE THE PATIENT MET WITH THE MDT REP AND THEIR CONCERNS WERE RESOLVED BUT THE CAUSE OF THE EVENT REMAINS UNKNOWN. THE DEVICE REMAINS IMPLANTED. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED. THE EVENT WAS REVIEWED FOR PREVIOUS INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND NONE WERE NOTED. REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. THERE WERE NO REMEDIAL ACTIONS TAKEN AS A RESULT OF THE EVENT. THE INVESTIGATION OF THE DEVICE IS INCONCLUSIVE BECAUSE OF INSUFFICIENT EVENT INFORMATION. PRODUCT ID: 3889-28, LOT# V698092, IMPLANTED: (B)(6) 2011, : PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013 AND SHE "SEEMED TO BE DOING FINE". THE REPRESENTATIVE STATED HE WOULD FOLLOW UP WITH THE PATIENT'S HEALTHCARE PROVIDER (HCP) 30 DAYS FROM REPORT. NO FURTHER INFORMATION WAS KNOWN AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT PROGRAMMER WOULD NOT POWER UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS NOT GETTING RELIEF FOR HER OVER ACTIVE BLADDER (OAB) SYMPTOMS DURING THE NIGHT. IT WAS STATED THAT THE PATIENT WOULD WAKE UP 3 TIMES A NIGHT TO USE THE BATHROOM AND COULD NOT MAKE IT SO SHE "WET PADS." IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED HER HIP. THE PATIENT HAD SURGERY ON HER HIP ON (B)(6) 2012. IT WAS STATED THAT THE PATIENT TURNED HER DEVICE OFF FOR THE SURGERY. THE DEVICE WAS TURNED BACK ON AGAIN AFTER THE SURGERY WAS OVER AND HER CATHETER WAS REMOVED. IT WAS NOTED THAT THE DEVICE AS "WORKING WELL" AFTER THE PATIENT GOT HOME. THE PATIENT INCREASED HER STIMULATION FROM 2.5 TO 2.7 AMPLITUDE ON PROGRAM 2. IT WAS ALSO NOTED THAT THE PATIENT COULD NOT ALWAYS FEEL HER STIMULATION. APPROXIMATELY ONE MONTH LATER IT WAS REPORTED THAT THE PATIENT HAD NOT SEEN HER PHYSICIAN SINCE HER ANNUAL EXAM IN (B)(6) OF 2012. ABOUT ONE MONTH LATER IT WAS REPORTED THAT THE PATIENT NO LONGER HAD CONCERNS WITH HER DEVICE OR THERAPY "AT THIS TIME." IT WAS NOTED THAT THE PATIENT HAD RECEIVED ASSISTANCE FROM HER MEDTRONIC REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. THE PATIENT MET WITH THE COMPANY REPRESENTATIVE ON (B)(6) 2012. ABOUT 6 WEEKS LATER IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS THE THERAPEUTIC EFFECT AND THAT HER OAB SYMPTOMS HAD INCREASED AT NIGHT. THE PATIENT HAD BEEN ENGAGING IN VARIOUS EXERCISES INVOLVING HER HIP AREA. THE PATIENT WAS CONCERNED THAT THE STATIONARY BIKE SHE WAS RIDING WAS RESPONSIBLE FOR THE LOSS OF THERAPY. IT WAS STATED THAT THE BATTERY WAS NEARING END-OF-LIFE (EOL). IT WAS ALSO STATED THAT THE PATIENT COULD NOT ADJUST HER STIMULATION WITH OR WITH THE ANTENNA. ABOUT ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS HAS "CHANGED" SINCE HER FALL AND FRACTURED HIP IN (B)(6). IT WAS NOTED THAT THE PATIENT WOULD "WET" PADS, UP TO 4 PADS A NIGHT. IT WAS STATED THAT THE PATIENT HAD "SOME ISSUES," BUT IT HAD GOTTEN WORSE AFTER HER FALL. IT HAD PREVIOUSLY BEEN REPORTED THAT THE PATIENT'S DEVICE WAS WORKING WELL AFTER HER HIP SURGERY. IT WAS UNCLEAR IF THE DEVICE HAD OR HAD NOT WORKED EFFECTIVELY AFTER HER HIP SURGERY. ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS ALSO NOTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THE DOCTOR OR REPRESENTATIVE. IT WAS NOT CLEAR IF THE PATIENT'S CONCERNS WERE RESOLVED OR NOT. AN APPOINTMENT WAS NOTED FOR (B)(6) 2013. FURTHER INFORMATION HAS BEEN REQUESTED. IF MORE INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83931 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention