FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1161204
·
Received September 15, 2008
Report
- Report Number
- 3004209178-2008-05733
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 19, 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PUMP AND CATHETER HAS BEEN RETURNED TO THE MFR FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
AN INFECTION WAS REPORTED. NO PT SYMPTOMS WERE REPORTED. THE PUMP AND CATHETER WERE EXPLANTED. THE PUMP WAS USED TO DELIVER LIORESAL, CONCENTRATION AND DOSAGE WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
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 | 43 YR | Required Intervention | CATHETHER MODEL 8711 LOT# N156614028| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| IMPLANTED |