BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 6109091 · Received November 17, 2016

    Report

    Report Number
    3004209178-2016-24212
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    January 31, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NARRATIVE UPDATED TO EXCLUDE INFORMATION FROM A RELATED EVENT. REFER TO DESCRIBE EVENT OR PROBLEM FOR UPDATED EVENT DESCRIPTION. (B)(4) CAN BE DISREGARDED AS THEY ARE ATTACHED TO THE OTHER RELATED EVENT. DATE RECEIVED BY MFR: DATE CORRECTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD AN EXTREME SEVERE HEADACHE FOR 3 DAYS AND DOUBLE VISON WHICH CLEARED UP TO BLURRED. THE PATIENT STATED THAT THEY STARTING TAKING ANTIBIOTICS (WHICH HELPED WITH THE HEADACHES) DUE TO DENTAL WORK AND THOUGHT THEY MIGHT HAVE AN INFECTION BECAUSE OF SORENESS. THEY HAD A CAT SCAN AS WELL AS A MAGNETIC RESONANCE IMAGING (MRI) TO TRY AND DETERMINE THE CAUSE. THEY STATED THAT BECAUSE THE MRI WAS LIMITED THEY WERE NOT ABLE TO SEE ANYTHING BUT THEY THOUGHT IT WAS A MINI STROKE DUE TO PATIENT SYMPTOMS AT THE TIME. FOLLOW-UP WAS RECEIVED FROM THE HEALTHCARE PROVIDER WHO STATED THAT THE HEADACHE AS WELL AS VISION PROBLEMS WERE RESOLVED PRIOR TO THEIR OFFICE BEING NOTIFIED ABOUT THE EVENT BY THE PATIENT'S OPHTHALMOLOGIST. THEY ADDED THAT ALL DEEP BRAIN STIMULATION (DBS) EQUIPMENT WAS INTACT AND SCANS WERE NORMAL. THE HEALTHCARE PROVIDER REPORTED THAT THE PATIENT RECOUNTED THE EVENT AS AN EPISODE OF ALTERATION OF CONSCIOUSNESS. IT WAS REPORTED THAT THE PATIENT BECAME DIZZY AFTER STANDING UP AND STARTED BUMPING INTO THE WALL. IT WAS REPORTED THAT HER SPEECH BECAME SLURRED. THE PATIENT LAID DOWN AND FELL ASLEEP AND AFTER WAKING UP WAS UNABLE TO EFFECTIVELY USE THEIR LEGS, ARMS, OR HOLD UP THEIR HEAD. IT WAS STATED THAT THE PATIENT TOOK ALMOST A HALF HOUR TO GET TO THE PHONE AND WAS TOO WEAK TO HOLD IT ON THEIR OWN. THE EMERGENCY MEDICAL SERVICES WAS UNABLE TO GET THE PATIENT TO WALK TO THE STRETCHER AND HAD TO HELP THEM ONTO IT WHERE THEY THEN TRANSFERRED TO THE HOSPITAL. IT WAS REPORTED THAT THEY VOMITED ONCE AND THE SWALLOWING TEST FOUND SOME TIGHTNESS. THEIR BLOOD PRESSURE WAS REPORTED 70/30 AND AT THIS POINT HER STIMULATION WAS TURNED OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THERE WERE TIMES THEY HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF, AND THAT THEY WENT TO THE EMERGENCY ROOM WITH A MINI-STROKE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER AS WELL AS THE PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT SUSPECTS THAT THEY MAY HAVE HAD A MINI STROKE IN 2010 OR 2011. THEY HAD A CAT SCAN AS WELL AS A MAGNETIC RESONANCE IMAGING (MRI) TO TRY AND DETERMINE THE CAUSE. THEY STATED THAT BECAUSE THE MRI WAS LIMITED THEY WERE NOT ABLE TO SEE ANYTHING BUT THEY THOUGHT IT WAS A MINI STROKE DUE TO PATIENT SYMPTOMS AT THE TIME. THE HEALTHCARE PROVIDER REPORTED THAT THE PATIENT RECOUNTED THE EVENT AS AN EPISODE OF ALTERATION OF CONSCIOUSNESS. IT WAS REPORTED THAT THE PATIENT BECAME DIZZY AFTER STANDING UP AND ¿STARTED BUMPING INTO THE WALL.¿ IT WAS REPORTED THAT HER SPEECH BECAME SLURRED. THE PATIENT LAID DOWN AND FELL ASLEEP AND AFTER WAKING UP WAS UNABLE TO EFFECTIVELY USE THEIR LEGS, ARMS, OR HOLD UP THEIR HEAD. IT WAS STATED THAT THE PATIENT TOOK ALMOST A HALF HOUR TO GET TO THE PHONE AND WAS TOO WEAK TO HOLD IT ON THEIR OWN. THE EMERGENCY MEDICAL SERVICES WAS UNABLE TO GET THE PATIENT TO WALK TO THE STRETCHER AND HAD TO HELP THEM ONTO IT AND TRANSFERRED THEM TO THE HOSPITAL. IT WAS REPORTED THAT THEY VOMITED ONCE AND THE SWALLOWING TEST ¿FOUND SOME TIGHTNESS.¿ THEIR BLOOD PRESSURE WAS REPORTED 70/30 AND AT THIS POINT HER STIMULATION WAS TURNED OFF. THE PATIENT CONCLUDED THAT THE CAUSE OF THE MINI STROKE WAS NOT DETERMINED BUT THEY HAVE BEEN TAKING ONE ASPIRIN A DAY WITH NO LINGERING EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761440 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O