FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX
MDR report key: 3153078
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05815
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 7, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2006, 6947 IMPLANTABLE TACHY LEAD (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLDS WERE VARYING MORE THAN TWO VOLTS IN MEASUREMENTS. THE RA LEAD ALSO HAD OVERSENSING AND UNDERSENSING. THE RA LEAD WAS CAPPED AND NOT REPLACED BECAUSE ACCESS INTO THE VEIN WAS UNSUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256164 | CAPSUREFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R |