FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202363
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-00530
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- December 12, 2011
- Report Date
- April 23, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S PUMP RESERVOIR BECAME EMPTY (B)(6) 2011. APPROXIMATELY 4 MONTHS LATER IT WAS REPORTED THAT THE PATIENT WAS ¿KIND OF HALF COMATOSE SO THEY THINK HE'S IN PAIN¿. ALARMS HAD NOT BEEN NOTED AND IT WAS ¿ASSUMED THE ALARMS HAD BEEN SILENCED¿. IT WAS REPORTED APPROXIMATELY 1 MONTH LATER THE HCP WAS IN THE PROCESS OF WEANING THE PATIENT FROM THE PUMP BY DECREASING DOSAGE DUE TO ¿ALCOHOL AND OTHER PROBLEMS¿. THE PATIENT EXPERIENCED INCREASED PAIN BUT NO WITHDRAWAL SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302979 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR |