FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 1913459
·
Received November 12, 2010
Report
- Report Number
- 3007566237-2010-09374
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 8, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S CURRENT PUMP WAS IMPLANTED (B)(6) 2008. ON (B)(6) 2010, IT WAS REPORTED THE PUMP HAS NOW MALFUNCTIONED, AS EVIDENCED BY INDIUM STUDIES AND A DECREASE IN PT FUNCTION. THE CURRENT PUMP WAS THE PT'S THIRD PUMP IN LESS THAN 7 YEARS. THE PUMP DELIVERED BACLOFEN. SPECIFIC DEVICE AND PT INFORMATION WAS NOT REPORTED. SPECIFIC INFORMATION REGARDING THE PUMP MALFUNCTION WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |