FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1160012
·
Received September 12, 2008
Report
- Report Number
- 2182207-2008-05681
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- July 23, 2008
- Report Date
- August 14, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, IMPORTANT INFORMATION ON POTENTIAL MRI EFFECTS, PHYSICIAN COMMUNICATION (2008).
Description of Event or Problem · 1
IN 2008: HEALTH CARE PROVIDER REPORTS A CONFIRMED MOTOR STALL DUE TO MRI OR OTHER MEDICAL PROCEDURE. PATIENT IS EXPERIENCING DIARRHEA AND INCREASED PAIN. RECOVERY NOTED IN THE LOGS AFTER PUMP UPDATE. NO PATIENT OUTCOME WAS REPORTED. 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 II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709 |