FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1213073
·
Received October 23, 2008
Report
- Report Number
- 3004209178-2008-06845
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 24, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELL. THE HCP USED FLUOROSCOPY TO TRY TO FILL THE PUMP, BUT WAS UNABLE TO DO SO. THE PATIENT WAS TOLD THE PUMP WAS FLIPPED. 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 PUERTO RICO OPERATIONS CO. | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | CATHETER: MODEL 8709SC| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840 |