FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 2051890
·
Received April 12, 2011
Report
- Report Number
- 2649622-2011-05679
- Event Type
- Injury
- Date Received
- April 12, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S039
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS GRADUALLY INCREASING IN IMPEDENCE AND THRESHOLD A FEW MONTHS AFTER IMPLANT. A LEAD ALERT WAS TRIGGERED AS THE IMPEDANCE AND THRESHOLDS CONTINUED TO INCREASE. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND A NEW PACE/SENSE LEAD IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE S | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6935 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |