N
Patient 1
(B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9897239
- MDR report key
- 9897239
- Report number
- 3004209178-2020-06354
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA WOODWARD CLARK
- Address
- 7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | MDT PUERTO RICO OPERATIONS CO | LKK | 863740 | 863740 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 | 1. H |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE AT 30 MG/DAY VIA AN IMPLANTED PUMP. ON (B)(6) 2020 THE PATIENT REPORTED THAT ONCE BEFORE MAYBE 10 YEARS AGO OR LONGER HE HAD GONE TO THE ER (EMERGENCY ROOM) BECAUSE HE HAD GONE IN FOR A REFILL AND THEY PUT SOMETHING IN THE PUMP AND BY THE NEXT DAY HE WAS SICK AND SNEEZING AND SICK TO HIS STOMACH. AFTER ANOTHER DAY OR SO, HE WAS SICKER AND COULD HARDLY BREATH. HE WAS THEN IN A NAVY HOSPITAL 3 DAYS TRYING TO GET BETTER. IT WAS A WHOLE WEEK. HE WAS SENT FOR TESTS, MAYBE AN MRI, AND THEY SHOWED THE PUMP WAS WORKING FINE. HE WAS ALSO ON ORAL MEDICATIONS. THEY FOUND OUT WHAT WAS PUT IN THE PUMP WAS NOT SUPPOSED TO BE IN THERE. PER THE PATIENT, HE WAS NEVER TOLD IF THE MEDICATION OR DOSAGE/CONCENTRATION WAS INCORRECT. HE STATED THAT HE SEEMED TO BE GOING THROUGH WITHDRAWAL. NINE HOURS AFTER THEY REFILLED IT, HE WAS MUCH BETTER. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.