FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1053268
·
Received May 28, 2008
Report
- Report Number
- 3004209178-2008-02856
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP BECAME INFECTED SOON AFTER REPLACEMENT SURGERY. THE HCP PLANNED TO HAVE THE DRUG ADMINISTERED BY THE PUMP ANALYZED FOR CONTAMINATION. IT IS UNK IF THE PUMP WAS EXPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | PROGRAMMER: MODEL 8840, LOT # UNK| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J11317R43 |