FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 3990986
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08377
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 13, 2014
- Report Date
- May 15, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.
Additional Manufacturer Narrative · 1
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).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE AND WAS OVERSENSING WITH A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC). THE LEAD HAD A POSSIBLE FRACTURE. THE LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 471621 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Hospitalization| R |