FDA Adverse Event Death Summary report: N

MEDTRONIC MINIMED MMT 722 NAS PARADIGM INSULIN PUMP

MDR report key: 3233936 · Received July 15, 2013

Report

Report Number
MW5030925
Event Type
Death
Date Received
July 15, 2013
Date of Event
January 4, 2010
Report Date
July 4, 2013
Manufacturer
MEDTRONIC
Product Code
LZG
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY HUSBAND WAS WEARING INSULIN PUMP WHICH HAD RECENTLY BEEN REFILLED/BOLUSED, WAS DRIVING MOTOR VEHICLE, BECAME CONFUSED OF ENVIRONMENT AND ACTIONS, PASSED OUT BEHIND WHEEL, HIT CONCRETE POLE, KILLED. AS A RESULT OF THE FAILURE OF THIS INSULIN PUMP, MY HUSBAND WAS KILLED IN A MOTOR VEHICLE ACCIDENT, WHICH NOT ONLY KILLED HIM, BUT SERIOUSLY INJURED THREE OF MY GRANDCHILDREN, (B)(6) OF AGE, BUT ALSO FOUR OTHER INNOCENT VICTIMS AND A TOTAL OF 7 VEHICLES. WHEN I CONTACTED MEDTRONIC VIA TELEPHONE TO INQUIRE AS TO WHAT I SHOULD DO WITH THE INSULIN PUMP, THEY ASKED WHY I WAS RETURNING IT. I TOLD THEM OF MY HUSBAND DIED AFTER PASSING OUT BEHIND THE WHEEL. THAT IS WHEN MEDTRONIC STATED, IT SOUNDED LIKE THE PUMP MALFUNCTIONED. THEY MADE ARRANGEMENTS TO SEND A PACKAGE TO RETURN THE PUMP IN. AFTER DISCUSSING THIS MATTER WITH MY ADULT CHILDREN, WE DECIDED NOT TO RETURN THE PUMP TO MEDTRONIC FOR FEAR THEY WOULD NOT BE HONEST IN THEIR EVAL OF THE PUMP AND DENY LIABILITY. VEHICLE #1 WAS TRAVELING EAST BOUND ON (B)(6) TOWARDS ITS INTERSECTION WITH (B)(6). VEHICLE #2 WAS STOPPED AND YIELDING AT THE INTERSECTION AT (B)(6) WAITING TO TURN LEFT. DRIVER OF VEHICLE# 1 CROSSED TO THE NORTH SIDE OF (B)(6). AS HE CROSSED THE INTERSECTION APPARENTLY CONFUSED AS TO WHICH LANE WAS THE EASTBOUND TRAVEL LANE. AFTER THE DRIVER OF VEHICLE #1 REALIZED THE MISTAKE, VEHICLE #1 ACCELERATED AND MOVED SOUTH TOWARD THE PROPER LANE. VEHICLE #1'S FRONT DRIVER'S SIDE BUMPER STRUCK VEHICLE #2 FRONT DRIVER'S SIDE BUMPERS, CAUSING SLIGHT DAMAGE TO BOTH VEHICLES, AS VEHICLE #1 PASSED BY AFTER THE IMPACT, VEHICLE #1 LEFT THE SCENE WITHOUT STOPPING. NO INJURIES REPORTED. CASE REMAINS UNDER INVESTIGATION. IT APPEARED THAT THE UNK DRIVER WAS CONFUSED AND TRYING TO TRAVEL EASTBOUND IN THE (B)(6) WAS CURRENTLY OCCUPYING. THE MAN APPEARED TO BECOME VERY IRATE BEFORE REALIZING HIS MISTAKE. THE DRIVER ACCELERATED RAPIDLY WHILE STEERING TOWARD THE CORRECT LANE. VEHICLE #1 COLLIDED WITH VEHICLE #2 (DRIVER SIDE BUMPER TO DRIVER SIDE BUMPER) AS VEHICLE #1 PASSED. VEHICLE #1 DID NOT STOP, CONTINUING DOWN (B)(6). AN UNK WITNESS, WHO LEFT THE SCENE PRIOR TO MY ARRIVAL, PROVIDED THE TAG NUMBER (B)(6) TO (B)(6), STATING IT BELONGED TO VEHICLE #1. VEHICLE #1 WAS TRAVELING SOUTH ON (B)(6) ON THE INSIDE LANE, FOR AN UNK REASON, VEHICLE #1 CROSSED INTO THE NORTH BOUND LANES AT TRAFFIC. LEFT THE ROADWAY STRIKING A LIGHT POLE AND VEHICLE #2 IN THE PARKING LOT OF (B)(6). THIS IMPACT CAUSED A CHAIN REACTION WITH VEHICLES 3, 4, AND 5. ALL OCCUPANTS OF THE VEHICLES INVOLVED WERE TRANSPORTED TO THE MEDICAL CENTER FOR TREATMENT. THIS CASE IS PENDING FURTHER POLICE INVESTIGATION. CONFUSION LEADING TO UNCONSCIOUSNESS TO ACCIDENT TO DEATH. PARADIGM INSULIN PUMP: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
327655 MEDTRONIC MINIMED MMT 722 NAS PARADIGM INSULIN PUMP MEDTRONIC MINIMED MMT 722 NAS PARADIGM INSULIN PUMP LZG MEDTRONIC MMT-722 NAS

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death| H| L| O SOTALOL (BETAPACE), 80MG TAB 3X/DY| WARFARIN (COUMADIN), PO, 5MG TAB| HYDROCHLOROTHIAZIDE, PO, 50MG TAB 1X/DY| BENAZEPRIL (LOTENSIN), 20MG TAB 1X/DY| MELOXICAM (MOBIC), PO, 7.5MG TAB 1X/DY| 1XDAY VITAMIN| TERAZOSIN (HYTRIN), 2MG CAP, 1X/DY| CYCLOBENZAPRINE, 10MG TAB 1X/DY| TOPIRAMATE (TOPAMAX), PO, 25MG TAB 2X/DY| METFORMIN, 500MG TAB, 2X/DY, AM/PM W/M| BENAZEPRIL, 5MG TAB 1X/DY| POTASSIUM| EZETIMIBE (ZETIA), PO, 10MG TAB 1X/DY| PAROXETINE (PAXIL), PO, 30MG TAB 2X/DY| SIMVASTATIN (ZOCOR), PO, 20MG TAB 1@ BEDTIME| ROSIGLITAZONE, PO, 4MG TAB 1X/DY| NEXIUM (ESOMEPRAZOLE MAGNESIUM), 40MG CAP 1X/DY| VITAMIN D| CLOPIDOGREL (PLAVIX), 75MG TAB 1X/DY