FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1222432
·
Received November 5, 2008
Report
- Report Number
- 2182207-2008-07227
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- September 23, 2008
- Report Date
- October 10, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT UNDERWENT A SURGICAL REVISION DUE TO A SHEARED CATHETER. THE PATIENT'S PUMP HAD NOT BEEN USED AND HAD CONTAINED SALINE SINCE 2007. A COMBINATION MEDICATION WAS GOING TO BE TRIED SO THE PATIENT WAS REFERRED TO A NEW PAIN CLINIC. THE PHYSICIAN ORDERED A DYE STUDY TO BE PERFORMED IN 2008. THE DYE STUDY INDICATED THE INFUSION CATHETER HAD RUPTURED/SHEARED. THE CATHETER WAS REPLACED TWO MONTHS LATER. FOLLOWING THE CATHETER REPLACEMENT, THE PUMP WAS FILLED WITH MORPHINE AND WAS PROGRAMMED AT A MINIMUM RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# N004981015| PROGRAMMER MODEL 8840 LOT# UNKNOWN |