FDA Adverse Event
Injury
Summary report: N
CAPSURE SENSE
MDR report key: 2810674
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16291
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- May 8, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S034
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- 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'S RIGHT ATRIAL LEAD (RA) WAS DISCOVERED TO BE DISLODGED. THE RA LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT IS PARTICIPATING IN THE (B)(4) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SENSE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4574 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR| 5092 IMPLANTABLE PACING LEAD |