FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2842213
·
Received November 21, 2012
Report
- Report Number
- 3004209178-2012-10636
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- October 24, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: UNK. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT "SHORTLY AFTER" HER IMPLANT IN (B)(6) 2011, PATIENT'S CATHETER CAME OUT AND WRAPPED AROUND THE PUMP. PATIENT UNDERWENT A REVISION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
ADDITIONAL REVIEW INDICATED THAT THE PATIENT STATED THE PHYSICIAN COULDNT FIND THE HOLE TO REFILL THE PUMP, AND IT CAME TO FIND OUT THE CATHETER HAD DRIPPED OVER AND THE CATHETER WAS WRAPPED AOUND THE PUMP.
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 |