SPRINT QUATTRO
Report
- Report Number
- 2649622-2012-16437
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- August 1, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS RECEIVED, ANALYZED, AND OVERSENSING WAS NOTED AS ONE VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODE AT 170MS OCCURRED ON (B)(6) 2012. ADDITIONALLY, INTERFERENCE/NOISE WAS NOTED AS THE VENTRICULAR SHORT INVERVAL COUNT WAS 127445 COUNTS IN 52.64 DAYS BETWEEN (B)(6) 2012.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD OVERSENSING ONE DAY POST IMPLANT WHICH WAS NOT REPRODUCIBLE WITH ISOMETRICS. THE LEAD POLARITY WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS AS RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD OVERSENSING ONE DAY POST IMPLANT WHICH WAS NOT REPRODUCIBLE WITH ISOMETRICS. THE LEAD POLARITY WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS AS RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |