FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 4831590
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-05478
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- March 25, 2015
- Report Date
- March 25, 2015
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS WAS PERFORMED WITH NO ANOMALIES FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD AND BODY TISSUE/FIBROTIC GROWTH. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED DUE TO THE PATIENT HAVING A HIGH DEFIBRILLATION THRESHOLD. A NEW DUAL COIL LEAD WAS USED TO IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 375322 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR |