FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 3991553
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08056
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 4, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 MEDICAL PRODUCTS: PRODUCT ID SEDR01 IPG, IMPLANTED: (B)(6) 2010. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE WARNING ON THE RIGHT ATRIAL (RA) LEAD. THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION (AF) SO THE PHYSICIAN ELECTED TO CAP THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470497 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4568-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00091 YR | Hospitalization| R | 4092-52 LEAD |