SPRINT FIDELIS
Report
- Report Number
- 2649622-2013-00497
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 16, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND THAT THERE WAS HIGH RESISTANCE/IMPEDANCE WITH PATIENT ALERTS FOR RIGHT VENTRICULAR PACE LEAD IMPEDANCE ON (B)(6) 2012. WEEKLY PACE LEAD TREND DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX V. PACE EQUAL TO 888 TO 2176 OHMS PEAK BETWEEN (B)(6) 2012. OVERSENSING WITH VENTRICULAR NON-SUSTAINED TACHYCARDIA LESS THAN EQUAL TO 210 MS ON (B)(6) 2012. ALSO, THERE WAS INTERFERENCE NOISE WITH VENTRICULAR SHORT INTERVAL COUNT (V-SIC) EQUAL TO 3765 COUNTS, IN 6.24 DAYS, BETWEEN (B)(6) 2012.
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD IMPEDANCE GREATER THAN 2000 OHMS, OVERSENSING AND A SUSPECTED LEAD FRACTURE. IT WAS ALSO DETERMINED THAT THE RV LEAD WAS IMPLANTED APPROXIMATELY A MONTH AFTER THE USE BEFORE DATE. THE RV LEAD WAS GOING TO BE SURGICALLY REVISED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56563 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694865 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00051 YR | Hospitalization| R |