FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2831087
·
Received November 14, 2012
Report
- Report Number
- 3004209178-2012-10219
- Event Type
- Injury
- Date Received
- November 14, 2012
- Report Date
- October 19, 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
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATHETER 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), UNKNOWN. (B)(4).
Description of Event or Problem · 1
DURING DEVICE FOLLOW-UP AN INFECTION OF THE DEVICE POCKET WAS NOTED. THE PATIENT UNDERWENT SURGERY FOR SCAR EXCISION ON BACK SITE. THE PUMP WAS EXPLANTED AND THE CATHETER WAS EXTERNALIZED TO DETERMINE NEXT STEPS. IT WAS INDICATED THERE WAS NO ADVERSE EVENT OR INJURY TO THE PATIENT. THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE TO US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00005 YR | Required Intervention |