FDA Adverse Event Injury Summary report: N

MEDTRONIC SYNCHROMED INFUSION PUMP

MDR report key: 2003463 · Received February 22, 2011

Report

Report Number
MW5019508
Event Type
Injury
Date Received
February 22, 2011
Date of Event
August 23, 2010
Report Date
February 22, 2011
Manufacturer
MEDTRONIC
Product Code
LKK
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

NORMALLY I WAKE IN THE EVENING, AS I SLEEP DURING THE DAYS AND MY HUSBAND AND CHILDREN TRIED TO WAKE ME TO TAKE MY PILLS BUT THEY COULD NOT GET ME TO WAKE UP. I AM ON ORAL MORPHINE, AS WELL AS HAVING AN IMPLANTED INTRATHECAL MORPHINE PUMP, WHICH WAS IMPLANTED IN 2003 INITIALLY, THEN WHEN THAT BATTERY WAS GETTING LOW, THEY IMPLANTED A NEWER LARGER PUMP ON (B)(6) 2007. IT IS A MEDTRONIC PUMP MODEL # 863740 AND SERIAL # (B)(4). ON (B)(6) 2010, MY FAMILY SIMPLY COULD NOT WAKE ME UP ONE EVENING WHEN IT WAS TIME FOR ME TO GET UP. MY HUSBAND (B)(6) COUNTED ALL MY ORAL MORPHINE TO MAKE SURE I HADN'T ACCIDENTLY TAKEN TOO MUCH, AND SAID THE COUNTS WERE FINE, AND THEY ALL FIGURED IT HAD SOMETHING TO DO WITH MY PUMP, SO MY OLDEST DAUGHTER WHO LIVES WITH US GOT ME DRESSED AND MY HUSBAND TOOK ME TO THE ER. THEY WERE EXTREMELY BUSY SO I WAS ONE OF 12 OTHER PEOPLE BEING HELD ON (B)(6) OUT IN THE ER HALLWAYS, AND EVEN THOUGH I AM EXTREMELY MODEST, I WAS OUT OF IT THAT I ACTUALLY LET THEM TAKE MY CLOTHING OFF, INCLUDING MY BRA, RIGHT THERE IN THE OPEN HALLWAYS IN FRONT OF THE OTHER DRS, NURSES, PTS, VISITORS, ETC. MY HUSBAND ASKED IF HE COULD RUN TO GET A CHEESEBURGER SINCE IT WOULD BE QUITE AWHILE BEFORE THEY GOT TO ME, SO I SAID YES, ALTHOUGH I DON'T REMEMBER IT. RIGHT AFTER HE LEFT, A DR INJECTED ME W/ NARCAN, AND THEN WALKED AWAY. HE DID NOT TELL ME WHAT TO EXPECT OR ANYTHING. I COULD LITERALLY FEEL THAT MEDICINE COURSING THROUGH EACH AND EVERY VEIN IN MY BODY, BECAUSE MY PAIN WAS A 12 WITHIN SECONDS, AND NOT JUST IN MY BACK AND LEGS LIKE NORMAL, BUT EVERYWHERE! I WAS SHAKING HORRIBLY, AND CRYING OUT FOR SOMEONE, ANYONE FOR THAT MATTER TO COME AND HELP ME, BUT NO ONE CAME, AND THIS WENT ON FOR ALMOST 30 MINUTES. I EVEN ASKED A FEW VISITORS TO PLEASE GET ME A DR OR NURSE, BUT STILL NO ONE CAME. AND AS IF ALL THIS EXTRA PAIN ISN'T BAD ENOUGH, THE DRS AND NURSES THERE TREATED ME AS THOUGH I WERE SOME DRUG ADDICT COME IN OFF THE STREETS OR SOMETHING. IT WAS THE MOST PAINFUL AND HUMILIATING EXPERIENCE I HAVE EVER BEEN THROUGH IN MY ENTIRE LIFE. WHEN (B)(6) CAME IN AND SAW ME SCREAMING, CRYING AND SHAKING SO BADLY, HE RAN TO MY BEDSIDE AND ASKED WHAT THEY HAD DONE TO ME, AND I TOLD HIM THEY GAVE ME SOMETHING CALLED NARCAN. (B)(6) SAID HE ASKED THE DR IF THERE WASN'T SOMETHING THEY COULD GIVE ME TO EASE THE PAIN AND SEVERE SHAKING, BUT HE SAID NO. THEN HE GOT REALLY SNOTTY WITH (B)(6) AND SAID "IT COULD BE MUCH WORSE YOU KNOW, I COULD JUST SHUT HER PUMP OFF FOREVER, IS THAT WHAT YOU WANT?" OF COURSE (B)(6) SAID NO. I CAME OUT OF THIS NARCAN IN EXTREME PAIN FROM HEAD TO TOE, WORST BEING BETWEEN MY LEGS, AND ALSO SEVERELY AGITATED. THE TOXICOLOGY SCREEN SHOWED NOTHING IN MY SYSTEM BESIDES MORPHINE. WE TRIED EXPLAINING TO THE DR AND THEN LATER MY PAIN DR THAT I DID NOTHING TO CAUSE THIS OVERDOSE, BUT THEY DID NOT BELIEVE ME. IN FACT, I JUST SAW A NEW PAIN MGMT DR TODAY WHO MAY BE TAKING MY CASE, HOPEFULLY!! THEN TONIGHT I SAW THE RECALL ON THE INTERNET, GOT OUT MY MEDTRONIC CARDS AND NOTICED THAT THE RECALL INCLUDES MY PUMP, AND THIS ARTICLE ALSO INCLUDED A LINK TO COME HERE TO FILL OUT THIS FORM. DATES OF USE: (B)(6) 2003 -(B)(6) 2007 AND (B)(6) 2007 - (B)(6) 201. DIAGNOSIS OR REASON FOR USE: LUMBAR ARACHNOIDITIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC SYNCHROMED INFUSION PUMP INTRATHECAL MORPHINE PUMP LKK MEDTRONIC 863740

Patients

Seq Age Sex Outcome Treatment
1 45 YR Hospitalization| L