FDA Adverse Event
Injury
Summary report: N
2649622-2014-09473
MDR report key: 3993153
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09473
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- March 24, 2014
- Report Date
- June 27, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST DUE TO A TRAUMATIC HEART BLOCK INDU CED BY THE GUIDEWIRE CATHETER. THE PATIENT WAS INTUBATED AND THE RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED TO PROVIDE PACING SUPPORT. INTUBATION WAS REMOVED BY THE END OF THE PROCEDURE AND THERE WERE NO FURTHER PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS REPORTED TO BE ENROLLED IN THE (B)(6) STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467906 | DTB | MPRI | MDT-GUIDEWIRE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| L| R |