FDA Adverse Event
Death
Summary report: N
ENTRUST AT
MDR report key: 1971336
·
Received January 27, 2011
Report
- Report Number
- 6000144-2011-00012
- Event Type
- Death
- Date Received
- January 27, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH (B)(6) AND RESPIRATORY FAILURE AND HAD THE ENTIRE SYSTEM (DEVICE AND TWO LEADS) REMOVED DUE TO (B)(6) ADVANCING TO PERICARDITIS. THE PATIENT'S CONDITION DID NOT IMPROVE AFTER DEVICE REMOVAL AND THE PATIENT EXPIRED 6 DAYS LATER. NO ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE OR LEADS.
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 | 65 YR | Death| H| L| O| R |