FDA Adverse Event
Injury
Summary report: N
CAPSURE VDD-2
MDR report key: 2954486
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02239
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- MPRI
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL PORTION OF THE LEAD DISPLAYED HIGH IMPEDANCE. THE LEAD WAS THEN PROGRAMMED OFF DUE TO THE PATIENT'S PERMENANT ATRIAL FIBRILLATION AND LEFT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58559 | CAPSURE VDD-2 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MPRI | 5038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR | Required Intervention |