FDA Adverse Event
Malfunction
Summary report: N
ENTRUST AT
MDR report key: 1864744
·
Received October 12, 2010
Report
- Report Number
- 6000144-2010-05252
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- August 16, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- 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 MULTIPLE ATTEMPTS OF ANTI TACHYCARDIA PACING (ATP) IN OFFICE FAILED TO BREAK A PATIENT'S SLOW VENTRICULAR TACHYCARDIA, AND THAT HIGH VOLTAGE THERAPY WAS BEING WITHHELD DUE TO THE ONSET DEVICE FEATURE. THE DEVICE IS STILL IN USE. 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 | 70 YR | Other | 6944 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |