FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1062927
·
Received June 19, 2008
Report
- Report Number
- 3004209178-2008-03314
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- February 15, 2008
- Report Date
- May 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS EXPLANTED. INFO PROVIDED INDICATED "MRSA PUMP AND TISSUE REC'D. TISSUE FROM AROUND PUMPS". NO OTHER INFO WAS PROVIDED.
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 | 49 YR | Required Intervention | CATHETER MODEL 8709 LOT# J0177989R| EXPLANTED| PROGRAMMER MODEL 8840 LOT # UNK| IMPLANTED |