FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1346952
·
Received February 9, 2009
Report
- Report Number
- 3004209178-2009-00785
- Event Type
- Malfunction
- Date Received
- February 9, 2009
- Report Date
- January 12, 2009
- 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE NEW CATHETER WAS TWISTED LIKE THE PREVIOUS ONE THAT WAS REPLACED. THE PATIENT WAS AT HOME. SHE WAS IN A LOT OF PAIN. THE PATIENT WAS ENCOURAGED TO CONTACT HER PHYSICIAN. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WEILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MANUFACTURER'S REPORT #6000030-2007-04552 FOR PREVIOUS CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER| ACCESSORY: MODEL 8590-1| PROGRAMMER: MODEL 8840 |