FDA Adverse Event
Death
Summary report: N
INSYNC II MARQUIS
MDR report key: 1013397
·
Received March 10, 2008
Report
- Report Number
- 6000094-2008-00082
- Event Type
- Death
- Date Received
- March 10, 2008
- Date of Event
- September 18, 2007
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC II MARQUIS | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC S.A. | 7289 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |