FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1153092
·
Received September 8, 2008
Report
- Report Number
- 2182207-2008-05529
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 10, 2008
- Manufacturer
- MEDTRONIC 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
RESULTS: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED LACK OF EFFECT DESPITE DOSE INCREASES. THE PUMP CONTAINED DILAUDID. A "SLIGHT RESERVOIR VOLUME DISCREPANCY' WAS REPORTED. A CATHETER DYE STUDY AND A PUMP ROLLER STUDY WERE PERFORMED AND FAILED TO IDENTIFY ISSUES. THE PT WAS TAKEN TO SURGERY WHERE IT WAS DETERMINED THAT THE 40 DEGREE PUMP CONNECTOR WAS COMPLETELY DETACHED FROM THE PUMP PORT. A NEW CATHETER WAS IMPLANTED.
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 | CATHETER MODEL 8709 LOT# J12178R24| PROGRAMMER MODEL 8840 LOT #UNK| IMPLANTED| EXPLANTED |