FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 2951419
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00103
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 2, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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 CONTINUED: 5076 IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NO IMPEDANCE MEASUREMENT ON THE SUPERIOR VENA CAVA (SVC) COIL AND HAD HIGH IMPEDANCE ON THE RV COIL. 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 |
|---|---|---|---|---|---|---|---|
| 55653 | SPRINT FIDELIS | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | D334DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |