SPRINT QUATTRO SECURE S
Report
- Report Number
- 2649622-2013-00570
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- July 13, 2012
- Report Date
- November 20, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR OF THE LEADWAS EXTRINSICALLY OVER-ROTATED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THE OVERLAY TUBING OF THE LEAD WAS EXTRINSICALLY BREACHED DUETO A CUT, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.
THIS EVENT OCCURRED OUTSIDE 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).
PRODUCT EVENT SUMMARY: (B)(4) - PRODUCT PERFORMANCE DATA WAS RECEIVED AND ANALYZED. OVERSENSING WAS NOTED AS ONE VENTRICULAR NON-SUSTAINED EPISODE WAS 200 MS ON (B)(6) 2012.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND WAS POSSIBLY FRACTURED. OVERSENSING WAS INDUCED DURING PATIENT EXERCISING BUT WAS NOT INDUCED WITH POCKET MANIPULATION. DURING THE REVISION PROCEDURE, THE PHYSICIAN FOUND BLOOD IN ALL HEADER CONNECTORS. NO OVERSENSING WAS NOTED ON THE LEAD AFTER REMOVAL. BOTH THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND WAS POSSIBLY FRACTURED. OVERSENSING WAS INDUCED DURING PATIENT EXERCISING BUT WAS NOT INDUCED WITH POCKET MANIPULATION. DURING THE REVISION PROCEDURE, THE PHYSICIAN FOUND BLOOD IN ALL HEADER CONNECTORS. NO OVERSENSING WAS NOTED ON THE LEAD AFTER REMOVAL. BOTH THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING AND WAS POSSIBLY FRACTURED. OVERSENSING WAS INDUCED DURING PATIENT EXERCISING BUT WAS NOT INDUCED WITH POCKET MANIPULATION. DURING THE REVISION PROCEDURE, THE PHYSICIAN FOUND BLOOD IN ALL HEADER CONNECTORS. NO OVERSENSING WAS NOTED ON THE LEAD AFTER REMOVAL. BOTH THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55856 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00032 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |