FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3863420
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06631
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- March 7, 2014
- Report Date
- March 7, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. PRODUCTS: 419488 LEAD IMPLANTED: 2012 (B)(6); 407652 LEAD IMPLANTED: 2012 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CURRENT ELECTROCARDIOGRAM (EGM) ON REMOTE TRANSMISSION SHOWED ONE INTERVAL OF POST VENTRICULAR PACE (VP) T-WAVE OVERSENSING (TWOS). 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 |
|---|---|---|---|---|---|---|---|
| 341242 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | (B)(4) ICD |