SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2013-12715
- Event Type
- Injury
- Date Received
- October 9, 2013
- Report Date
- August 15, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). THERE WERE TEN NON-SUSTAINED (NST) EPISODES LESS THAN 220 MILLISECONDS (MS). V-V CYCLE ARE RECORDED BETWEEN (B)(4) 2013. 485 V-SIC OCCUR SINCE (B)(4) 2013. LIA TRIGGERED ON (B)(4) 2013 DUE TO MEETING THE CONDITIONS FOR ABNORMAL LEAD IMPEDANCE AND V-SIC. MAXIMUM V PACE IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 500 OHM TO GREATER THAN 950 OHM THE WEEK ENDING (B)(4) 2011.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: D224VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2009. (B)(4).
PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT NON-PHYSIOLOGICAL NOISE WAS BEING OVERSENSED BY THE RIGHT VENTRICULAR (RV) LEAD AND THERE WERE A HIGH NUMBER OF SHORT V-V INTERVALS WHICH TRIGGERED A LEAD INTEGRITY ALERT (LIA). POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED TO TURN DETECTIONS OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT NON-PHYSIOLOGICAL NOISE WAS BEING OVERSENSED BY THE RIGHT VENTRICULAR (RV) LEAD AND THERE WERE A HIGH NUMBER OF SHORT V-V INTERVALS WHICH TRIGGERED A LEAD INTEGRITY ALERT (LIA). POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED TO TURN DETECTIONS OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2014: IT WAS LATER REPORTED THAT THE LEAD WAS EXPLANTED.
IT WAS REPORTED THAT NON-PHYSIOLOGICAL NOISE WAS BEING OVERSENSED BY THE RIGHT VENTRICULAR (RV) LEAD AND THERE WERE A HIGH NUMBER OF SHORT V-V INTERVALS WHICH TRIGGERED A LEAD INTEGRITY ALERT (LIA). POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED TO TURN DETECTIONS OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513378 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention |