SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2013-00839
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- November 8, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNT (SIC) AND THE IMPEDANCE OF THE RIGHT VENTRICULAR (RV) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. THE ANALYST COMMENTED THAT 16 NONSUSTAINED VENTRICULAR TACHYCARDIA EVENTS OF LESS THAN 200 MILLISECONDS V-V INTERVAL OCCURRED BETWEEN (B)(6) 2007. THE MAXIMUM RV PACE WEEKLY VALUES ROSE TO A HIGH OF 1680 OHMS THE WEEK OF 2007-11-07 AND THE WEEKLY MAXIMUM RV PACE IMPEDANCES VARIED WIDELY BETWEEN THE WEEKS OF (B)(6) 2007 (448 OHMS UP TO 1424 OHMS).
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUDDEN IMPEDANCE INCREASE, HIGH PACING IMPEDANCE, WAS EXHIBITING NOISE AND HAD AN INCREASED SENSING INTEGRITY COUNT (SIC). THE RV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59736 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Hospitalization| R |