BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3259989 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-12638
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    July 9, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V872660, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (LOT # NJY184772H ) SHOWED NO ANOMALY FOUND.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PATIENT GOT A SHOCK WHENEVER SHE PLUGGED ¿SOMETHING IN FOR THE LAST COUPLE MONTHS.¿ THE REPORTER STATED THAT ACCORDING TO THE CLINICIAN PROGRAMMER, THE STIMULATION HAD NOT BEEN ON SINCE MAY. THE CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. THE REPORTER TURNED THE STIMULATION ON AND THE PATIENT FELT IT AT LOW AMPLITUDES. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT WAS HAVING SHOCKING SENSATION WITH PLUGGING INTO ELECTRICAL OUTLETS. THERE WAS NO ABNORMAL IMPEDANCE MEASUREMENT. IT WAS INDICATED THAT PATIENT WAS HAVING OUT THIGH STIMULATION, AFTER REPROGRAMMING THEN FELT STIMULATION IN MID PERI AREA. IT WAS NOTED THAT ON 2013 (B)(6) PATIENT WAS SEEN IN THE ER DUE TO ¿SHOCKING SENSATION AND PAIN¿.THE PATIENT WAS NOT HOSPITALIZED. IT WAS INDICATED THAT ON 2013 (B)(6) IT WAS NO LONGER OCCURRING, PATIENT WAS NOT PLUGGING APPLIANCE IN, OTHER FAMILY MEMBERS WERE DOING IT FOR HER. IT WAS INDICATED ON THE DAY OF THIS REPORT THEY WERE NO NEW UPDATES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTS A NEUROSTIMULATOR AND LEAD WAS COMPLETELY EXPLANTED THE DAY BEFORE REPORTED EVENT DATE. IT WAS REPORTED THAT THE PATIENT REPORTED SHOCKING/JOLTING SENSATION AND THE DEVICE WAS EXPLANTED. THE PATIENT REPORTED ELECTRICAL SHOCK WHEN STANDING NEXT TO ELECTRICAL OUTLET. THE REPRESENTATIVE WAS INFORMED OF THE EXPLANT AND ISSUE AFTER THE EXPLANT OCCURRED. IT WAS REPORTED THAT PAIN WAS ASSOCIATED WITH THIS EVENT. IT WAS LATER REPORTED THAT THE NEUROSTIMULATOR WAS NOT REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTS THE NEUROSTIMULATOR WILL BE RETURNED. IT WAS ALSO REPORTED THE SYSTEM WAS COMPLETELY EXPLANTED AND PATIENT WAS DOING WELL PER HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359587 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention