FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3200031
·
Received July 1, 2013
Report
- Report Number
- 2182207-2013-00003
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Date of Event
- June 13, 2006
- Report Date
- June 13, 2006
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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 PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A MOTOR STALL OCCURRED. THE STALL WAS CAUSED BY READING THE PUMP WITH A MAGNET. IT WAS LATER REPORTED THAT THE SITUATION WAS RESOLVED. THE MOTOR STALL RECOVERED LESS THAN 10 MINUTES LATER. THE PATIENT DID NOT EXPERIENCE SYMPTOMS AND THERE WAS NO TREATMENT DONE SINCE THE STALL RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298994 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |