FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1843590
·
Received September 22, 2010
Report
- Report Number
- 3007566237-2010-07187
- Event Type
- Injury
- Date Received
- September 22, 2010
- Report Date
- August 24, 2010
- 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 PT'S PUMP POCKET WAS "SQUISHY." THE CATHETER WAS DISCONNECTED FROM THE PUMP. THE PARTIAL DISCONNECT PROBLEM WAS AT THE PUMP/CATHETER CONNECTOR. IT WAS PLANNED TO CUT OFF THE OLD CONNECTOR AND ADD A SUTURELESS CONNECTOR TO THE EXISTING CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER: MODEL 8709, LOT# J10908R24| IMPLANTED:| EXPLANTED: |