FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1834602
·
Received September 9, 2010
Report
- Report Number
- 3007566237-2010-06903
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Date of Event
- January 1, 2009
- Report Date
- August 18, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A MRI PERFORMED "ALMOST A YEAR AGO," AND ONE WEEK LATER PRESENTED TO THE PT'S PHYSICIAN COMPLAINING OF FEELING "FLOPPY." WHEN THE PT'S PUMP WAS INTERROGATED, IT WAS NOTED THAT THE SETTINGS WERE "COMPLETELY DIFFERENT." THE PUMP WAS RESET AND THE PT DID "FINE." NO FURTHER DETAILS OR PT SYMPTOMS WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N110855001 |