FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3030943
·
Received April 2, 2013
Report
- Report Number
- 3004209178-2013-04478
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 5, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INFECTION WAS NOTED AT THE PUMP SITE. CULTURES WERE TAKEN BUT RESULTS OF THE CULTURES WERE NOT KNOWN. THIS DEVICE SYSTEM WAS SUBSEQUENTLY EXPLANTED AND THE PATIENT WAS REPORTED TO BE DOING "OK." THIS SYSTEM DELIVERED GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134875 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |