BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 12298788 · Received August 9, 2021

    Report

    Report Number
    3004209178-2021-12125
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 20, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3889-28, LOT#: VA1Z8CU, IMPLANTED: (B)(6) 2019, EXPLANTED: (B)(6) 2021, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 04-APR-2023, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE DOCTOR REMOVED THE INS AND LEAD SO THE PATIENT (PT) COULD HAVE AN MRI. THE CALLER REPORTED THE LEAD BROKE DURING EXPLANT AND A LEAD FRAGMENT REMAINED IN THE PT. TECHNICAL SERVICES (TS) TRANSFERRED CALLER TO OFFICE OF MEDICAL AFFAIRS (OMA) FOR INFORMATION ON LEAD FRAGMENT AND MRI. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) ON 2021-AUG-04. THE HCP CALLED BACK ON 2021-AUG-04 AND AGAIN REPORTED THE PATIENT WAS NEEDING AN MRI OF THEIR LOWER BACK AND SCIATICA (NOT ALLEGED TO BE RELATED TO THE DEVICE/THERAPY.) THEY STATED THE HCP ALREADY REVIEWED THE INFORMATION FROM THE OFFICE OF MEDICAL AFFAIRS (OMA) BUT NOTED THE HCP DID NOT FIND IT HELPFUL. THE CALLER WAS AGAIN INQUIRING IF THE PATIENT COULD HAVE AN MRI. TECHNICAL SERVICES REVIEWED THAT IT WAS A MEDICAL DECISION TO PROCEED WITH AN MRI AND THAT THE SAFETY OF SCANNING A PORTION OF THE LEAD WAS NOT ADDRESSED IN MRI LABELING. AS THE PATIENT¿S HCP HAD ALREADY CONSULTED WITH OMA, TECHNICAL SERVICES COULD NOT PROVIDE ANY ADDITIONAL ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191594 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR