FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2073598
·
Received April 26, 2011
Report
- Report Number
- 3007566237-2011-03098
- Event Type
- Injury
- Date Received
- April 26, 2011
- Date of Event
- February 23, 2011
- Report Date
- April 11, 2011
- Manufacturer
- MEDTORNIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT'S PUMP WAS EXPLANTED DUE TO BEING AT ITS END OF LIFE. AT THE TIME OF PUMP REPLACEMENT, THE CATHETER WAS NOTED AS HAVING BEEN BRITTLE, AND HAD BROKE/FELL APART IN THE SURGEON'S HANDS. THE CATHETER BREAK OCCURRED AT THE PIN CONNECTING SITE. THE CATHETER WAS REPLACED. THE PT DID NOT REQUIRE HOSPITALIZATION, AND THE PT'S OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELAE. THE MEDICATION ADMINISTERED VIA THE PUMP WAS MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTORNIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT #B011422N12 |