BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7731134 · Received July 30, 2018

    Report

    Report Number
    3004209178-2018-16827
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    November 1, 2017
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3889-28, LOT# VA1F9KL, IMPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD; PRODUCT ID: 3889-28, LOT# VA09HDS, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: VA1F9KL, (B)(6), (B)(4). APPLIES TO BOTH TINED LEAD, 3889-28, INTERSTIM (VA1F9KL) AND IPG 3058 INTERSTIM LL ((B)(4)) . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION. 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 VIA A MANUFACTURE REPRESENTATIVE (REP) 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 A PAIN AT THE IMPLANT SITE. THE PATIENT HAD PAIN AT THE INS AND LEAD INSERTION SITE. THE REP STATED THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS NOTED THERE WERE LEAD IMPEDANCES LESS THAN 4000 AND GREATER THAN 50 ON ALL COMBINATIONS. THE REP STATED THE LEAD WAS RETUNNELED DEEPER AND THE INS PLACED HIGHER AND DEEPER. IT WAS NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT REPORTED PAIN OVER THE INS AND LEAD INSERTION SITE. THE LEAD AND INS WERE EASILY PALPATE. THE REP NOTED THE PATIENT WOULD WINCE IN PAIN WITH BARELY TOUCHING HER SKIN OVER THE SITE. THE HCP RETURNNELED THE LEAD AND PLACED THE INS A LITTLE HIGHER AND DEEPER. THE PATIENT WAS LISTED AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572295 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention