FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2812099
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15910
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S2
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- 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 THE PATIENT PRESENTED TO THE CLINIC WITH ATRIAL FIBRILLATION BUT INTERMITTENT UNDERSENSING COULD BE SEEN. IT WAS ALSO THOUGHT THAT THE DIAGNOSTICS WERE UNDER REPORTING OF THE AMOUNT OF ATRIAL FIBRILLATION. THE PATIENT WAS SCHEDULED FOR A CARDIOVERSION. THE LEAD REMAINS 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 | CAPSUREFIX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| R | ADDR01 IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD |