FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1023517
·
Received April 2, 2008
Report
- Report Number
- 2182207-2008-01718
- Event Type
- Malfunction
- Date Received
- April 2, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 7, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT CAME TO THE HOSPITAL BECAUSE THE HEARD THE ALARM SOUND. THE PUMP WAS FOUND TO BE IN SAFETY MODE AT A MINIMUM FLOW RATE. THE PUMP GAVE A CRITICAL ALARM EVERY 10 MINUTES. AFTER TWO REPROGRAMMING ATTEMPTS, THE PUMP ALWAYS RETURNED TO THE ALARM SOUND AND SAFETY MODE WITHIN A COUPLE OF MINUTES. THE PUMP WAS REPLACED. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER MORPHINE. IT WAS UNCLEAR HOW LONG THE PUMP HAD BEEN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |