BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7897343 · Received September 21, 2018

    Report

    Report Number
    3004209178-2018-21207
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    August 1, 2018
    Report Date
    October 2, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    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

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# VA1MFFZ, IMPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DATE IS APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE IMPEDANCE ISSUES WAS NOT DETERMINED. THE INTERVENTIONS TAKEN WERE TURNING THE DEVICE OFF AND SCHEDULING THE PATIENT FOR A LEAD REVISION. THE DEVICE CURRENTLY REMAINED IN THE PATIENT, BUT WAS TURNED OFF.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY/SYMPTOM CONTROL. CALLER REPORTED THAT SOME IMPEDANCES WERE >4000 AND SOME WERE <(><<)>50. THE MANUFACTURER REPRESENTATIVE (REP) WAS CALLING AND WAS WITH THE PATIENT AND HEALTHCARE PROVIDER TO DO TROUBLESHOOTING. THERE WERE NO KNOWN ACTIVITIES/EVENTS THAT PROMPTED THE REPORTED ISSUE. CALLER REPORTED THAT IMPEDANCES WERE TAKEN AT 300 PW, 5V. THEY HAD PREVIOUSLY TAKEN THEM AT DIFFERENT AMPLITUDES AND KEPT 300 PW. NO HISTORICAL IMPEDANCES WERE AVAILABLE: C0 >4000 C1 >4000 C2 >4000 C3 >4000 01 >4000 02 >4000 03 >4000 12 <(><<)>50 13 <(><<)>50 23 <(><<)>50 TROUBLESHOOTING STEPS WERE REVIEWED. CALLER WAS DIRECTED TO FOLLOW-UP WITH THE HEALTHCARE PROVIDER REGARDING THE POSSIBILITY OF A LEAD REVISION. IT WAS REPORTED THE PATIENT HAD EXPERIENCED A GRADUAL RETURN IN URINARY SYMPTOMS. PRIOR TO AUGUST THE PATIENT REPORTED GOOD SYMPTOM CONTROL. CALLER NOTED A DECLINE IN SYMPTOM CONTROL FOR ABOUT 2 WEEKS AND THEN THE PATIENT CHANGED THEIR PATIENT PROGRAMMER BATTERIES TO CHECK THE INS. NO FALLS WERE NOTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740443 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention