SPRINT QUATTRO
Report
- Report Number
- 2649622-2012-14726
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING: 11 - VENTRICULAR NST<=210 MS BETWEEN (B)(6) 2011 15:32:45 AND (B)(6) 2012 07:44:37. 5 - LFP HIGH RATE-NS <= 197 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012 06:14:01 AND (B)(6) 2012 09:42:47. SENSING - INTERFERENCE/NOISE: VENTRICULAR SHORT INTERVAL COUNT V-SIC=12.7 COUNTS AVG/DAY, IN 1.89 DAYS, BETWEEN (B)(6) 2012 16:29:35 AND (B)(6) 2012 13:50:02. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED: 4 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2011 15:25:07 AND (B)(6) 2012 10:21:17.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE AND A NON-SUSTAINED TACHYCARDIA (NST) EPISODE. IT WAS ALSO NOTED THAT THE LEAD WAS IMPLANTED AFTER THE USE BEFORE DATE. THE DEVICE WAS REPROGRAMMED AND 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 |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | D364TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5594 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD |