FDA Adverse Event
Injury
Summary report: N
ENTRUST AT
MDR report key: 1013480
·
Received March 10, 2008
Report
- Report Number
- 6000144-2008-00045
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- October 22, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DETAILED ANALYSIS OF THE LEAD WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
ASKU
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST AT | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154ATG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | 4592 IMPLANTABLE PACING LEAD |