FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 3992484
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09858
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 27, 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
- 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. CONCOMITANT: PRODUCT ID 5076-45 NON DEFIB LEAD IMPLANTED: 2005-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO THE OVERSENSING CRITERIA. THERE WAS HIGH SHORT INTERVAL COUNTS (SIC) AND TRUE VENTRICULAR TACHYCARDIA (VT) WITH SOME OCCASIONAL DOUBLE COUNTING OF WIDE QRS. THE RIGHT VENTRICULAR (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 |
|---|---|---|---|---|---|---|---|
| 466854 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | DDBB1D1 ICD |