FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2993251
·
Received March 7, 2013
Report
- Report Number
- 3004209178-2013-03445
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 28, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER MODEL 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS NOTED THE ANCHOR DEPLOYMENT TOOL WAS RETURNED WITH REMNANTS OF SILICONE STILL REMAINING ON THE HYPOTUBE. THE ANOMALY OBSERVED WAS LIKELY RELATED TO SILICONE BLOCKING THAT OCCURRED BETWEEN THE INTERACTION OF THE ANCHOR AND THE HYPOTUBE. THE CATHETER ANCHOR DID NOT PROPERLY DETACH FROM THE ASCENDA TOOL; NOT ABLE TO USE.
Description of Event or Problem · 1
DURING DEPLOYMENT OF ANCHOR DEVICE, THE PHYSICIAN HAD DIFFICULTY; THE CATHETER ANCHOR JAMMED AND PART OF THE ANCHOR REMAINED ON DISTANT END OF DEPLOYMENT DEVICE. THE ENTIRE CATHETER WAS IMPLANTED. THERE WAS NOT INJURY RELATED TO EVENT. PATIENT RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97994 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR |