FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3202742
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-06126
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- May 20, 2012
- Report Date
- April 10, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A CONFIRMED MOTOR STALL WITH NO MOTOR STALL RECOVERY RECORDED. THE MOTOR STALL WAS CAUSED BY THE PATIENT HAVING AN MRI OR OTHER MEDICAL PROCEDURE. IT WAS LATER REPORTED THE MOTOR STALL RECOVERED WHEN INTERROGATED AGAIN MINUTES LATER. EVERYTHING SHOWED TO BE RUNNING AS IT SHOULD HAVE BEEN. THE PUMP CONTAINED LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301857 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00035 YR |