FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 1865218
·
Received October 6, 2010
Report
- Report Number
- 3007566237-2010-07668
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 9, 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
IT WAS REPORTED A HEALTH CARE PROVIDER WAS INTERROGATING A PUMP AND REC'D A PUMP MEMORY ERROR (PME) INVALID TELEMETRY MESSAGE AND WAS UNABLE TO CLEAR IT. IT WAS RECOMMENDED THAT THE PUMP BE RE-INTERROGATED AND TO TRY INTERROGATING ANOTHER PROGRAMMER. IT WAS NOT KNOWN IF THERE WAS A THERAPY OR MEDICAL PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK |