FDA Adverse Event
Malfunction
Summary report: N
CAPSUREFIX
MDR report key: 3153589
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-06105
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE 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. CONCOMITANT PRODUCTS: 407658 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WITHIN A FEW WEEKS POST-IMPLANT, THERE WAS HIGH ATRIAL IMPEDANCE. 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 |
|---|---|---|---|---|---|---|---|
| 257231 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | ADDR01 IMPLANTABLE PULSE GENERATOR |