FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4164567
·
Received October 10, 2014
Report
- Report Number
- 3005619263-2014-00009
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 6, 2014
- Report Date
- August 6, 2014
- Manufacturer
- TYRX, INC.
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 DURING THE IMPLANT PROCEDURE, THE ENVELOPE HAVE INCREASED THE DEFIBRILLATION THRESHOLD. THE ENVELOPE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT AT IMPLANT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH DEFIBRILLATION THRESHOLDS. THE RV LEAD WAS NOT IMPLANTED AND A NEW RV LEAD USED. THE NEW RV LEAD HAD HIGH DEFIBRILLATION THRESHOLDS, AND 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 |
|---|---|---|---|---|---|---|---|
| 644450 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | TYRX, INC. | 6947M62 | 14F23471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00027 YR | DVBB1D4, ICD, 6947M62, LEAD |