FDA Adverse Event Injury Summary report: N

MEDTRONIC SYNCHROMED

MDR report key: 7914713 · Received September 26, 2018

Report

Report Number
MW5080180
Event Type
Injury
Date Received
September 26, 2018
Date of Event
September 19, 2018
Report Date
September 25, 2018
Manufacturer
MEDTRONIC INC.
Product Code
FRN
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE A MEDTRONIC INTRATHECAL PAIN PUMP MODEL #8637-20. THIS IS MY 2ND PUMP AND HAVE IT 1 1/2 YRS. HAD MY FIRST PUMP FOR 7 YEARS (SAME MODEL). I DEVELOPED SEVERE/NEW/UNUSUAL BACK PAIN AT ABOUT 3:00AM. THEN VOMITED FOR HOURS, FREEZING/BURNING UP, WITH HIGH BP, AND SEVERE JERKING OF MY LEGS. I WAS IN WITHDRAWAL FROM THE MORPHINE AND CLONIDINE IN MY PUMP. I WAS UNFAIRLY NEGLECTED AT THE ER, EVEN THOUGH I INFORMED THEM THAT I HAD A PAIN PUMP AND HAD A HEART ATTACK. I WAS SCREENED AND THEN LEFT IN THE ER FOR 7 HOURS DRY HEAVING, AND MORE. BP AT ONE POINT WAS 223/110. I WAS ADMITTED AND FINALLY GIVEN IV MORPHINE. KIDNEY STONES AND UTI WERE RULED OUT. IT WAS 24 HOURS LATER THAT I WAS NO LONGER JERKING / THROWING UP, ETC. MY PAIN SPECIALIST IS AT A LOSS AS TO WHAT HAPPENED. TESTING ON MY PUMP DID NOT SHOW THAT IT STALLED, NOR DID IT EVER ALARM. HE ALSO DID A "SIDE STUDY" TO CHECK THE FLOW OF THE CATHETER. IT WAS APPARENTLY "FINE." THE ONLY OTHER SOLUTION IS THAT I WILL HAVE THE RECENT PUMP MEDS EXTRACTED AND HAVE A NEW BATCH INJECTED THIS THURSDAY AND THE CONTENTS WILL BE ANALYZED, I HAD JUST HAD IT REFILLED 2 1/2 WEEKS AGO. I WAS GIVEN A 3 DAY FENTANYL PATCH TO HOLD ME OVER THE WEEKEND UNTIL I GOT INTO MY PAIN SPECIALIST, WHO DENIES KNOWING OF ANY RECALL ON THIS DEVICE. I WILL LIKELY GET A SECOND OPINION, ESPECIALLY SINCE MY RESEARCH THUS FAR SHOWS THAT THIS PARTICULAR PUMP WAS INTACT RECALLED. I BECAME VERY LETHARGIC AND SLEEPY, SO I REMOVED THE PATCH AND INFORMED MY DR. THE PAIN SPECIALIST HAS NO IDEA "WHAT TO DO WITH ME." THIS PUMP SHOULD LAST 7 YEARS AND TO HAVE IT REPLACED IS A SIGNIFICANT SURGERY. THE PUMP HAS NOT YET BEEN REMOVED OR REPLACED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
751918 MEDTRONIC SYNCHROMED INFUSION PUMP FRN MEDTRONIC INC. 8637-20
751919 MEDTRONIC SYNCHROMED INFUSION PUMP FRN MEDTRONIC, INC. 8637-20

Patients

Seq Age Sex Outcome Treatment
1 57 YR Hospitalization| L| O| R