FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 2864770
·
Received December 10, 2012
Report
- Report Number
- 2649622-2012-17503
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- October 3, 2012
- Report Date
- February 5, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT THE DISTAL ELECTRODE WAS COVERED (NOT OBSTRUCTED) WITH BLOOD. THERE WAS OUTER INSULATION DEPRESSION AND COSMETIC ENVIRONMENTAL STRESS CRACKING ON THE OVERLAY TUBING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE LEAD MAY HAVE BEEN DAMAGED. 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 SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00082 YR | Hospitalization| R |