FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1296827
·
Received December 1, 2008
Report
- Report Number
- 3004209178-2008-07813
- Event Type
- Malfunction
- Date Received
- December 1, 2008
- Report Date
- October 29, 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
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS CODE USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER DISCONNECTED FROM THE PUMP. NO PT SYMPTOMS WERE REPORTED. THE PT REPORTED THAT THIS HAS HAPPENED 4 TIMES AND THAT SHE PLANNED TO HAVE THE PUMP REMOVED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE ALSO MFR REPORT #S: 2182207-2008-02623; 2182207-2008-07812; 2182207-2008-07814.
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 | EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709SC |