FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 3991339
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08180
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 6, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Removal / Correction Number
- Z-0070-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH PACING, SUPERIOR VENA CAVA (SVC) COIL, AND RIGHT VENTRICULAR (RV) COIL IMPEDANCES ON THE RV LEAD. NOISE, SHORT INTERVAL COUNTS (SIC), INSULATION DAMAGE, AND A FRACTURE WERE ALSO NOTED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468801 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| R | 7232CX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |