FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2951384
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00112
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- October 31, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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) 2012. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD SEVERAL EPISODES OF VENTRICULAR TACHYCARDIA/VENTRICULAR FIBRILLATION (VT/VF) THAT WAS NOT DETECTED DUE TO SIGNIFICANT UNDERSENSING OF THE RIGHT VENTRICULAR LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 56981 | SPRINT FIDELIS | ELECTRODE, PACEMAKER, PERMANENT | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00086 YR | Life Threatening | 5076 IMPLANTABLE PACING LEAD |