FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2982635
·
Received February 28, 2013
Report
- Report Number
- 3004209178-2013-03148
- Event Type
- Injury
- Date Received
- February 28, 2013
- Report Date
- February 1, 2013
- 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CATHETER: MODEL 8709SC SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), CATHETER MODEL 8596SC SERIAL# (B)(4), IMPLANTED: 2009 (B)(6). (B)(4).
Description of Event or Problem · 1
THE PATIENT WAS ALSO IRRITABLE, HAD A FEVER, AND WAS SHAKING. THE CATHETER WAS REVISED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS DELIVERING GABLOFEN.
Description of Event or Problem · 1
THERE WAS A DISTAL SEGMENT CATHETER KINK. IT WAS NOTED THAT SURGICAL INTERVENTION WAS REQUIRED, NOT DATE OR EXPLANATION WAS GIVEN. PATIENT SYMPTOMS WERE ALTERED MENTAL STATUS, INCREASED SPASTICITY AND UNDERDOSE SYMPTOMS. PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE, NO INJURY, NO ADVERSE EVENT. 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 |
|---|---|---|---|---|---|---|---|
| 88011 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |