FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 1651571
·
Received April 2, 2010
Report
- Report Number
- 3007566237-2010-02692
- Event Type
- Death
- Date Received
- April 2, 2010
- Report Date
- March 9, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (6): THE PUMP WAS RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
THE PT WAS DECEASED. THE PUMP WAS NOT DEFECTIVE. THE CAUSE OF THE DEATH AND ITS RELATIONSHIP WITH THE IMPLANTED PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED. A F/U 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 | Death | CATHETER: MODEL 8709, LOT #: N067223008| IMPLANTED:| PROGRAMMER: MODEL 8832, LOT #: NJG003014N| EXPLANTED: |