FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3043058
·
Received April 9, 2013
Report
- Report Number
- 3004209178-2013-04911
- Event Type
- Injury
- Date Received
- April 9, 2013
- Report Date
- March 11, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPIRATION DATE OF THE PUMP WAS UPDATED/CORRECTED.
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED A (B)(4) STUDY WAS PERFORMED AND THE RESULTS HAD REVEALED A "QUESTIONABLE LEAK". THE OUTCOME TO THE PATIENT WAS "NO INJURY".
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PATIENT EXPERIENCED AN INCREASE IN SPASTICITY. A PUMP CONNECTOR BREAK AND A CATHETER LEAK APPROXIMATELY FIVE INCHES FROM THE PUMP WERE REPORTED. A CATHETER REVISION WAS PERFORMED. THIS DEVICE SYSTEM DELIVERED LIORESAL. 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 |
|---|---|---|---|---|---|---|---|
| 145426 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |