BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2944270 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-01317
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WAS REPROGRAMMED (PERSONALLY SUPERVISED BY THE PHYSICIAN) TO OPTIMIZE PARASTHESIA PAIN COVERAGE WITH THE FOLLOWING PARAMETERS AFFECTED: PULSE AMPLITUDE, PULSE DURATION, PULSE FREQUENCY, STIMULATION TRAIN DURATION, AND NUMBER OF PROGRAMS, ALTERNATING ELECTRODE POLARITIES, AND DOSE TIME. AFTER THE REPROGRAMMING SESSION THE PATIENT FELT LIKE THEY WERE GOING TO 'PASS OUT.' THE MANUFACTURER'S REPRESENTATIVE GOT THE PHYSICIAN WHO NOTED THAT THE PATIENT WAS SEATED IN A CHAIR. THE PATIENT HAD BOTH CAROTID AND RADIAL PULSES. THE PATIENT APPEARED PALE AND THEIR BLOOD PRESSURE WAS MEASURED AT 168/110 WITH A HEART RATE OF 75 AND A PULSE OX OF 95%. THE PATIENT WAS ABLE TO FOLLOW COMMANDS ALTHOUGH THEY WERE NOT ABLE TO COMPLETELY OPEN THEIR EYES. THE PATIENT WAS ABLE TO MOVE THEIR ARMS AND LEGS BUT HAD A WEAK GRIP. THEY WERE ABLE TO STICK THEIR TONGUE OUT AND WAS MUMBLING. IT WAS NOTED THAT THE PATIENT HAD NOT HIT THEIR HEAD. EMERGENCY RESPONSE WAS NOTIFIED AND 5 LITERS OF OXYGEN BY CONTINUOUS NASAL CANNULA WAS ADMINISTERED. THE PATIENT WAS CONTINUOUSLY MONITORED AND WAS ABLE TO FOLLOW COMMANDS BUT WAS NOTED TO BE DROWSY. THE PHYSICIAN'S IMPRESSION WAS NOTED AS SYNCOPE, POSSIBLE SEIZURE, OR POSSIBLE STROKE. THE PATIENT WAS TRANSFERRED PER EMS TO THE EMERGENCY ROOM AND REMAINED IN STABLE CONDITION. ADDITIONAL FOLLOW UP INFORMATION OBTAINED REPORTED THAT THE PATIENT'S BLOOD PRESSURE WAS ELEVATED BUT STABLE ALTHOUGH PALE. THE PATIENT HAD NOT BEEN SEEN BY THE PHYSICIAN SINCE THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEN THE "END SESSION" BUTTON ON THE PHYSICIAN PROGRAMMER WAS PRESSED DURING A PROGRAMMING SESSION, THE PATIENT STATED "SHE WAS GOING TO FAINT" AND THEN LOST CONSCIOUSNESS. THE REPORTER INDICATED THAT THE PATIENT DID NOT HAVE A HISTORY OF STROKES OR FAINTING, ALTHOUGH THE PATIENT HAD FAINTED ONCE, 20 YEARS PRIOR TO THE REPORT. THE PATIENT WAS ATTENDED BY HER HEALTHCARE PROVIDER (HCP) WHILE WAITING FOR AN AMBULANCE TO TRANSPORT THE PATIENT TO A HOSPITAL. THE PATIENT REGAINED CONSCIOUSNESS BUT COULD ONLY PARTIALLY OPEN HER EYES, WHEN ASKED TO, AND COULD SLIGHTLY SQUEEZE A HAND. THE PATIENT COULD HOWEVER NOT HOLD HER HEAD UP. THE PATIENT'S STIMULATION WAS SHUT OFF BEFORE THE AMBULANCE ARRIVED. IT WAS NOTED THAT THE PATIENT'S LEADS WERE IN THE THORACIC REGION AND SHE WAS GETTING STIMULATION IN HER LOW BACK, BUTTOCK AND LEGS. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY A WEEK LATER INDICATED THAT PROGRAMMING WENT AS NORMAL AND THERE WERE NO MALFUNCTIONS SEEN. THE REPORTER DIDN'T KNOW HOW THE PATIENT WAS DOING AFTER THE INCIDENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47944 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization