FDA Adverse Event
Injury
Summary report: N
ENTRUST AT
MDR report key: 1013549
·
Received March 10, 2008
Report
- Report Number
- 6000144-2008-00039
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- February 5, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST AT | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154ATG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other | 6949 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD |