BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2342039 · Received November 18, 2011

    Report

    Report Number
    3004209178-2011-09254
    Event Type
    Injury
    Date Received
    November 18, 2011
    Report Date
    October 25, 2011
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3986A, LOT # N208353, IMPLANTED: (B)(6) 2009; EXTENSION MODEL 748940, SERIAL # (B)(4); PROGRAMMER MODEL 7434A, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3986A, LOT# N071535, IMPLANTED: 2009 (B)(6), EXPLANTED: 2009 (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION FOLLOWING A REVISION IN (B)(6) 2009. IT WAS UNKNOWN WHY THE PATIENT HAD A REVISION, AND AFTER THE REVISION THE PATIENT STARTED EXPERIENCING 'ZAPPING' AT THE LEAD LOCATION. THE PATIENT COULD ONLY USE THE STIMULATION COMFORTABLY WHILE LYING DOWN IN A 'PARTICULAR' POSITION, OTHERWISE THE PATIENT WOULD EXPERIENCE THE 'ZAPPING'. THE PATIENT WOULD ALSO EXPERIENCE THE ZAPPING WHENEVER HE WENT OVER A BUMP IN HIS VEHICLE. THE PATIENT WAS GOING TO HAVE A BACK FUSION ON (B)(6) 2011. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED TO UNDER HIS SHOULDER BLADE, RESULTING IN THE (B)(6) 2009 REVISION. FOLLOWING THE REVISION IF THE PATIENT PULLED A MUSCLE IN HIS BACK HE GOT SHOCKED AND ZAPPED. IT WAS ALSO NOTED THAT THE PATIENT HAD A TENDER SPOT WHERE THE REVISION TOOK PLACE. THE PATIENT STATED THAT HE HEARD A NOISE IN HIS EARS WHEN HE WAS SHOCKED. IT WAS REPORTED THAT THE PATIENT WAS TOLD THERE MIGHT BE SOME LIQUID WHERE THE CONTACTS WERE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD PAIN ALONG THE LEAD ENTRY SITE, MIDLINE OF THE PATIENT'S BACK. THIS PAIN ONLY OCCURRED WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON, AND HAS BEEN PRESENT SINCE IMPLANT. THE PAIN ONLY OCCURRED AT HIGH VOLTAGES. IMPEDANCES APPEARED TO BE NORMAL. A REPROGRAMMING ATTEMPT WAS MADE AT THE TIME. THE NEXT DAY IT WAS REPORTED THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR A POSSIBLE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A WIRE CAME LOOSE AND IT ENDED UP UNDER THE RIGHT SHOULDER BLADE. IT WAS NOTED THAT IN (B)(6) 2009 THE DOCTOR RECONNECTED THE WIRE. IT WAS NOTED THAT BEFORE THE WIRE CAME LOOSE IT WORKED GREAT. IT WAS NOTED THAT THE WIRE CAME LOOSE AFTER (B)(6). IT WAS NOTED THAT THE PATIENT WAS SITTING IN THE HOUSE AND FELT SOMETHING POP BUT DID NOT HURT ANYWHERE. IT WAS NOTED THAT THE PATIENT FELT A TWINGE UNDER THE SHOULDER BLADE. IT WAS NOTED THAT THE PATIENT DID NOT KNOW IF THAT WAS THE WAY IT WAS IMPLANTED AND THE PATIENT DID NOT KNOW WHAT HAPPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BETWEEN (B)(6) 2012 THE PATIENT HAD A LEAD WIRE COME LOOSE UNDER HIS RIGHT SHOULDER BLADE. IT WAS STATED THAT THE DOCTOR "RECONNECTED" THE LEAD AND EVERYTHING WAS "FINE FOR ABOUT A MONTH". THE COMPANY RECORDS INDICATE THAT THE PATIENT HAD A REVISION IN (B)(6) 2009. AFTER A MONTH THE PATIENT STARTED TO FEEL SHOCKING (REFER TO MANUFACTURER REPORT # 3004209178-2013-00543 FOR INFORMATION ON EVENTS THAT HAPPENED AFTER THE REVISION). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LEAD REVISION IN 2009. IT WAS STATED THAT THE PATIENT WAS SITTING IN A RECLINER AND WHEN HE GOT UP HE FELT A "POP". IT WAS NOTED THAT NOTHING HAD BOTHERED THE PATIENT BEFORE THE "POP". IT WAS STATED THAT THE PATIENT LEANED OVER AGAIN TO GET OUT OF THE RECLINER AND HE FELT A "PULL" AND THEN THE ZAPPING STARTED. IT WAS REPORTED THAT AN X-RAY REVEALED THAT THE LEAD HAD MIGRATED TO UNDER THE PATIENT'S RIGHT SHOULDER BLADE. IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention