FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2823392
·
Received November 7, 2012
Report
- Report Number
- 3004209178-2012-10024
- Event Type
- Injury
- Date Received
- November 7, 2012
- Report Date
- October 10, 2012
- Manufacturer
- MDT 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
Additional Manufacturer Narrative · 1
PRODUCT ID, 8835 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4). FINAL ANALYSIS OF THE PUMP FOUND NO PUMP ANOMALY. FINAL ANALYSIS OF THE CATHETER FOUND ACCEPTABLE TESTING. THE CATHETER WAS RETURNED INCOMPLETE, IN SEGMENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP SYSTEM WAS EXPLANTED DUE TO INFECTION. NO OTHER INFORMATION WAS REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |