FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2810530
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15755
- 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
- TN, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE REMOTE TRANSMISSION SHOWED ATRIAL HIGH RATE (AHR) WHICH APPEARS TO BE NOISE. THE LEAD WILL BE TESTED AND THE POLARITY CHANGED. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE REMOTE TRANSMISSION DISPLAYED DUAL ELECTROCARDIOGRAM RECORDING. THE DEVICE 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. | 5068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | (B)(4) IMPLANTABLE PULSE GENERATOR| 5024M IMPLANTABLE PACING LEAD |