FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1220448
·
Received November 4, 2008
Report
- Report Number
- 3004209178-2008-07173
- Event Type
- Injury
- Date Received
- November 4, 2008
- Report Date
- October 7, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT'S PUMP ERODED A SECOND TIME. THE PUMP WAS AGAIN RELOCATED. REFERENCE MFR REPORT #3004290178200807171, 3004209178200807178, 3004209178200807180.
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 | Required Intervention | CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED: |