FDA Adverse Event
Injury
Summary report: N
CAPSURE FIX MRI
MDR report key: 2811449
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16376
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 20, 2012
- Report Date
- June 16, 2022
- Manufacturer
- MPRI
- Product Code
- NVN
- PMA / PMN Number
- P090013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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 THERE WAS T-WAVE OVERSENSING OBSERVED DURING VENTRICULAR PACING IN THE RIGHT VENTRICULAR LEAD. THE LEAD SENSITIVITY WAS DECREASED AND THE LEAD REMAINS IN USE. IT WAS REPORTED THAT THE PATIENT WAS ENROLLED IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE FIX MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) | NVN | MPRI | 5086MRI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |