FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1757171
·
Received June 18, 2010
Report
- Report Number
- 3007566237-2010-04895
- Event Type
- Malfunction
- Date Received
- June 18, 2010
- Date of Event
- May 24, 2010
- Report Date
- May 24, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THEY WERE UPDATING THE PUMP AND HAVING DIFFICULTY COMPLETING TELEMETRY WHEN THEY RECEIVED A PME (PUMP MEMORY ERROR) AND TELEMETRY WAS CANCELLED. TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING; THE ALARM WAS DUE TO A CRITICAL PME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |