BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7616413 · Received June 19, 2018

    Report

    Report Number
    3004209178-2018-13801
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    September 22, 2017
    Report Date
    July 3, 2018
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3889-28, LOT# V847778, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 11-OCT-2015. DEVICE EVALUATION CONCLUSION CODE PERTAINS TO BOTH IPG 3058 INTERSTIM LL ((B)(4)) AND TINED LEAD, 3889-28, INTERSTIM ((B)(4)). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V847778 EXPLANTED: (B)(6)2017 .IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THE PATIENT HAD THE INS REMOVED, THE PATIENT NOTED THE LEAD WIRE SNAPPED IN TWO AND THEY SAW THAT IN THE CAT SCAN. THE PATIENT STATED SHE WAS SUFFERING FROM SOME BLADDER ISSUES AND THEY WERE GETTING WORSE. THE PATIENT DECIDED TO GET THE INS REMOVED INSTEAD OF GETTING IT REPLACED. THE PATIENT NOTED THE LEAD WIRE SNAPPED IN TWO PROBABLY A YEAR AGO AND THEY HAD BLADDER ISSUES PROBABLY A YEAR AGO IN THE FALL. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT HAD MULTIPLE HEALTH ISSUES THAT CONTRIBUTED TO THE BLADDER IRRITATION THAT WERE UNRELATED TO THE INS. THE CAUSE OF THE LEAD BREAKING WAS NOT DETERMINED. THE INS WAS REMOVED ON (B)(6)2017 DUE TO THE BATTERY BEING AT END-OF-LIFE AND, PER THE PATIENT¿S CHOICE, IT WAS NOT REPLACED DUE TO THEIR HEALTH ISSUES. PER OPERATIVE NOTES, THE INS WAS REMOVED AND THE LEAD CUT (WITH GENTLE TRACTION ON THE LEAD). THE LEAD WAS ABLE TO BE GRASPED AND THEN IT SNAPPED FAIRLY EASILY. THE INCISION WAS OPENED UP SLIGHTLY, DISSECTED DOWN, AND THE LEAD WAS ABLE TO BE REMOVED IN ITS ENTIRETY UNDER DIRECT FLUOROSCOPY GUIDANCE. THE PATIENT WAS TAKE TO RECOVERY IN STABLE CONDITION. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457657 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention