FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1843365
·
Received September 22, 2010
Report
- Report Number
- 3004209178-2010-07181
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- August 30, 2010
- Report Date
- August 30, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A MOTOR STALL, CONFIRMED BY TELEMETRY, NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY DOCUMENTED IN THE EVENT LOG. THE MOTOR STALL WAS CAUSED BY THE PATIENT HAVING AN MRI AT 1542 ON (B)(6) 2010. THE DRUG, DOSAGE AND CONCENTRATION WERE UNKNOWN. PATIENT'S STATUS WAS UNAVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | IMPLANTED:| CATHETER: MODEL 8703W, LOT# L56468| EXPLANTED: |