BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE ADVANCED

    MDR report key: 3221314 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11630
    Event Type
    Death
    Date Received
    July 11, 2013
    Report Date
    June 18, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUS DATE OF DEATH REPORTED WAS AN ESTIMATE. DATE OF DEATH HAS BEEN CORRECTED TO ACTUAL DATE OF PATIENT DEATH.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377775, LOT# V002096, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    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 THE PATIENT FELL AND THE LEAD HAD MOVED DOWN. IT WAS NOTED WHEN OR HOW THE PATIENT LANDED WAS UNKNOWN. IT WAS FURTHER NOTED THE PATIENT¿S HEALTHCARE PROFESSIONAL WANTED TO MOVE THE LEAD UP, BUT A REVISION SURGERY HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION REPORTED THE PATIENT WOULD HAVE A REVISION, BUT THE DATE WAS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISLODGEMENT OF THE CERVICAL/THORACIC ELECTRODE OCCURRED AFTER A SEIZURE. IT WAS STATED THAT THE PATIENT WAS TO HAVE A REVISION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH REPLACEMENT OF AN ELECTRODE, REVISION OF LEAD AND EXTENSION CONNECTION SYSTEM, AND REVISION OF THE LEFT INS POCKET AND APPROPRIATE TUNNELING. IT WAS STATED THAT THERE WERE NO APPARENT COMPLICATIONS. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED PER PROTOCOL. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) USED FLUOROSCOPY TO IDENTITY THE EPIDURAL ACCESS SITE AT T3-T4. IT WAS STATED ELECTRODE WAS EASILY REMOVED WITHOUT ANY RESISTANCE OUT OF THE SPINAL CANAL. IT WAS REPORTED THAT THEY OPENED UP THE GLUTEAL INS POCKET, MOBILIZED THE INS AND ELECTRODES, AND CAREFULLY WITHDREW THE ELECTRODE FROM THE THORACIC SPINAL INCISION DOWN TO THE LEFT GLUTEAL INS SITE WITH THE ENTIRE SYSTEM REMOVED INTACT. IT WAS REPORTED THAT THE EPIDURAL ACCESS WAS ACHIEVED FROM A LEFT PARAVERTEBRAL APPROACH IN THE THORACIC SPINE AT THE T3-4 LEVEL. IT WAS STATED THAT IT WAS SOMEWHAT DIFFICULT TO GET AN APPROPRIATE ANGLE BECAUSE OF ARTHRITIC CHANGES THAT HAD OCCURRED SINCE THE PATIENT'S INITIAL IMPLANT IN 2008. IT WAS STATED THAT USING MULTIPLANAR VIEWS AND LOSS OF RESISTANCE TECHNIQUE, THEY ACHIEVED EPIDURAL ACCESS AT T3-4 AND AN EPIDURAL 8 CONTACT ELECTRODE WAS ADVANCED IN A LATERAL RECESS AS MUCH AS POSSIBLE UNTIL ITS TIP WAS NEAR THE C4 SEGMENT. IT WAS STATED THAT MULTIPLANAR VIEWS CONFIRMED THAT THE ELECTRODE ARRAY WAS IN THE DORSAL EPIDURAL SPACE. IT WAS REPORTED THAT BECAUSE OF PROGRESSIVE ARTHRITIC CHANGES AND MILD CERVICAL STENOTIC CHANGES, THEY WERE UNABLE TO GET ELECTRODE POSITIONING IN THE LATERAL RECESS IN THE UPPER SEGMENTS. IT WAS STATED THAT THE TEST STIMULATION SHOWED GOOD COVERAGE INTO THE RIGHT ARM AND PATIENT WAS SATISFIED WITH THE PAIN RELIEF. IT WAS STATED THAT THE BOTTOM OF THE ELECTRODE ARRAY WAS NEAR THE T1 SEGMENT WITH THE UPPER ASPECT NEAR THE MIDLINE AT APPROXIMATELY T4-T5. IT WAS REPORTED THAT A TUNNELING DEVICE WAS USED TO PASS THE EXTENSION FROM THE LEFT GLUTEAL INS SITE TO THE SPINAL INCISION. THE EXITING SPINAL ELECTRODE WAS CONNECTED TO THE EXTENSION DEVICE. IT WAS REPORTED THE INS WAS CONNECTED TO THE EXTENSION SITE AND THE SYSTEM WAS CHECKED. IT WAS FOUND TO BE PROPERLY FUNCTIONING. IT WAS REPORTED THAT ALL WOUNDS WERE COPIOUSLY IRRIGATED WITH BACITRACIN SOLUTION AND HEMOSTASIS CONFIRMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF DEATH HAD NOT YET BEEN CONFIRMED. IT WAS NOTED THAT THE PATIENT HAD BEEN GETTING GOOD STIMULATION AFTER THE NEW LEAD WAS PLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO DEVICE OR LEAD RELATED ISSUES, BUT THE PATIENT WAS HAVING A REVISION TOMORROW TO MOVE THE LEAD UP THE C4 AREA FOR BETTER THERAPEUTIC COVERAGE. THREE DAYS LATER, IT WAS REPORTED THE PATIENT HAD A LEAD REPLACED ON (B)(6) 2013. TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT PASSED ON A WEEK PRIOR TO THE REPORT. IT WAS NOTED THAT CAUSES MAY HAVE BEEN ATTRIBUTED TO AN OVERDOSE OF MEDICATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319914 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Death| R