FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 3861651
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07203
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 3, 2014
- Report Date
- March 3, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Removal / Correction Number
- Z-0070-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PRODUCTS: 5076-52 IMPLANTABLE PACING LEAD (B)(6) 2007; 419388 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH DEFIBRILLATION THRESHOLDS AND HIGH RV THRESHOLDS. THE RV 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 |
|---|---|---|---|---|---|---|---|
| 341504 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |