FDA Adverse Event
Death
Summary report: N
ATTAIN PERFORMA
MDR report key: 7303124
·
Received February 28, 2018
Report
- Report Number
- 2182208-2018-00321
- Event Type
- Death
- Date Received
- February 28, 2018
- Date of Event
- February 5, 2018
- Report Date
- March 1, 2018
- Manufacturer
- MEDTRONIC, PLC
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THE IMPLANT PROCEDURE WAS ABORTED DUE TO COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED, AND IT WAS LEARNED THERE WAS DIFFICULTY LOCATING A TARGET BRANCH. IT WAS ALSO REPORTED THE GUIDE WIRE, CATHETER, AND LEAD CONTINUALLY SLIPPED OUT OF THE CORONARY SINUS, THE PROCEDURE LASTED FOR HOURS, AND THE PATIENT ENDURED PERFORATIONS DUE TO WIRE PLACEMENTS. A REVIEW OF THE MANUFACTURERS DATA BASE REVEALED THE PATIENT IS DECEASED. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146133 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MEDTRONIC, PLC | 4298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death| H| L | 6250V-3D CATHETER, UNKNOWN COMPETITOR GUIDE WIRE |