BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY ENHANCED

    MDR report key: 7656660 · Received July 2, 2018

    Report

    Report Number
    3007566237-2018-01952
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    June 7, 2018
    Report Date
    May 24, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID: 309101, LOT# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE; PRODUCT ID: 305901, LOT# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP HAD CALLED REGARDING COMPATIBILITY GUIDELINES FOR THE PATIENT WHO CUT PART OF THEIR PNE LEAD (THE REP REITERATED THE PATIENT HAD CUT THEIR OWN PNE WIRE,) WHEN THEY HAD THEIR PNE TRIAL DONE. THE REP ALSO NOTED THE PATIENT HAD A SUCCESSFUL TRIAL. THE REP REPORTED THAT NOW THE HEALTH CARE PHYSICIAN (HCP) WANTED TO DO AN MRI OF THE PELVIS AND PER X-RAY THERE HAD BEEN SOME SMALL, MAYBE AN INCH LEFT FRAGMENTS SCATTERED. MRI COMPATIBILITY WAS REVIEWED FOR THE PNE LEAD AND ABANDONED SYSTEM. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 309101, LOT# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 309101, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD CUT THEIR PNE WIRES DURING BASIC EVALUATION AND WAS SCHEDULED FOR IMPLANT TWICE AND WAS A NO SHOW. THE PATIENT WAS IMPLANTED ON 8/24/18. DURING THE PRE-OP INTERVIEW AND CONFIRMED UNDER FLUORO AT THE IMPLANT, THE PATIENT REMOVED THE LEFT PNE LEAD. IT WAS CONFIRMED THE RIGHT PNE LEAD REMAINED IMPLANTED. THE PATIENT WAS IMPLANTED WITH THEIR PERMANENT SYSTEM AND THE RIGHT PNE LEAD REMAINED IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2018 AS REPORTED PREVIOUSLY. THE PATIENT DID NOT SHOW UP FOR SURGERY, AND AT THIS POINT, THE HEALTHCARE PROVIDER'S (HCP) OFFICE HAS BEEN UNABLE TO REACH THEM TO RESCHEDULE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT FELT PAIN ON THE LEFT SIDE AND SORENESS AT THEIR INCISION SITE. AS A RESULT OF WHAT WAS REPORTED, THEY WERE ADVISED TO CALL THEIR HEALTHCARE PROVIDER (HCP). FIVE DAYS LATER, THE PATIENT'S MANUFACTURE REPRESENTATIVE (REP) WAS NOTIFIED THAT THE PATIENT CUT THEIR LEADS ON THEIR OWN. THE PATIENT WAS HAVING GREAT RESULTS AND WAS READY TO MOVE TOWARD IMPLANT. THEY MISSED THEIR LEAD PULL APPOINTMENT, BUT WHEN THE HCP'S OFFICE REACHED OUT TO THEM, THE PATIENT REMOVED THEIR BANDAGE, NOTICED THE WIRES HANGING DOWN AND TOOK IT UPON THEMSELVES TO CUT THEM. AT THE TIME OF THIS REPORT, THE HCP ORDERED AN X-RAY FOR THE PATIENT TO DETERMINE IF THE WIRES WERE REMOVED COMPLETELY OR NOT. ADDITIONAL INFORMATION RECEIVED FROM A REP ON (B)(6) 2018 WHO CONFIRMED THE INFORMATION WITH THE HCP. REP SAID THE PATIENT WAS INSTRUCTED TO IMMEDIATELY GET AN X-RAY SO THEY COULD DETERMINE IF ANY PORTION OF THE LEAD REMAINED IN THE BODY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON (B)(6) 2018 WHO OBTAINED THE INFORMATION FROM THE HCP. THE PATIENT GOT AN X-RAY WHICH CONFIRMED THAT THE LEADS WERE INSIDE THEM. THEY ARE STILL SCHEDULED FOR IMPLANT ON (B)(6) 2018, AT WHICH POINT, THE LEADS WILL BE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497644 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention