FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2010576
·
Received March 1, 2011
Report
- Report Number
- 3007566237-2011-01534
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 14, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY WITH INCREASED PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE WITHDRAWAL SYMPTOMS. THE PUMP LOGS SHOWED THAT THE PUMP WAS IN SAFE STATE AND A RESET HAD OCCURRED. THE PHYSICIAN REPROGRAMMED THE PUMP AND SET THE PUMP TO SIMPLE CONTINUOUS MODE AND DECREASED THE DOSE IN HALF. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# N002897320 |