FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 6007451
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-12680
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- July 20, 2016
- Report Date
- July 28, 2016
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) STORM. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO A HIGH SENSING INTEGRITY COUNTER (SIC) AND NON-SUSTAINED TACHYCARDIA EPISODES ON THE RIGHT VENTRICULAR (RV) LEAD WITH SOME DOUBLE COUNTING DURING ARRHYTHMIAS. THE LEAD WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655941 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Hospitalization| R | 507645 LEAD, DDMB1D4 ICD |