FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3173687
·
Received June 17, 2013
Report
- Report Number
- 3004209178-2013-10478
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 27, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8784 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID: 8781 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE SYSTEM WAS REMOVED DUE TO INFECTION. THE PATIENT EXPERIENCED INCREASED SPASTICITY RELATED TO THE EVENT. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE - NO INJURY/NO ADVERSE EVENT¿. THE PUMP WAS DELIVERING GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273752 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00015 YR | Hospitalization| R |