FDA Adverse Event
Malfunction
Summary report: N
ENTRUST AT
MDR report key: 1922800
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05987
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- August 28, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 GREAT VARIATIONS IN THE PERCENTAGE OF PACING FOR BOTH THE ATRIUM AND THE VENTRICLE WERE BEING SEEN ON THE CARDIAC COMPASS. DEVICE IS STILL IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
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 | 79 YR | Other | (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD |