FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2191757
·
Received July 22, 2011
Report
- Report Number
- 3007566237-2011-05691
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 5, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 RETURN OF SYMPTOMS. THE PT HAD AN MRI EIGHT DAYS BEFORE THE EVENT WAS REPORTED. THE PUMP LOG WAS NOT READ FOLLOWING THE MRI, BUT THE PUMP LIKELY STARTED SHORTLY AFTER THE MRI WAS COMPLETE. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED; A FOLLOW UP REPORT WILL BE SUBMITTED IF ADD'L INFO 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 | CATHETER: MODEL 8709, LOT # N086296001| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT # J12566R20 |