FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1213789
·
Received October 28, 2008
Report
- Report Number
- 2182207-2008-06956
- Event Type
- Injury
- Date Received
- October 28, 2008
- Date of Event
- September 27, 2008
- Report Date
- September 30, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS CODE: USED FOR THE CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED DIFFICULTY SWALLOWING, AND CONSTIPATION WHICH BEGAN IN 2008. IT WAS SPECULATED THAT THERE MAY BE A POSSIBLE "DEFECT" OR DISLODGEMENT OF THE CATHETER. THE EVAL WAS ON-GOING AT THE TIME OF THIS REPORT.
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 | 49 YR | PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709 |