FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 2964492
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01939
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- November 28, 2012
- Report Date
- November 28, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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. CONCOMITANT PRODUCT: D334DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE POST IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PAIN DURING RESPIRATION. THE RIGHT ATRIAL LEAD THRESHOLD HAD INCREASED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. THE PATIENT'S PAIN WAS RESOLVED AND THE THRESHOLD NUMBERS WERE NORMAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67296 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |