SPRINT QUATTRO
Report
- Report Number
- 2649622-2012-17133
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- November 6, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY (B)(4): THE ACTUAL LEAD INVOLVED IN THE EVENT WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. NOISE/OVERSENSING: (B)(4) - VENTRICULAR NST<(><<)>(><(><<)><(><<)>)>=210 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 15:53:11 AND 19:07:28. (B)(4) - VF <(><<)>(><(><<)><(> <<)>)>=190 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012 13:51:28 AND (B)(6) 2012 11:14:53.
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.
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS, AND IT WAS DETERMINED THAT THE SHOCKS WERE DUE TO NOISE. THE LEAD WAS CUT, CAPPED, AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS, AND IT WAS DETERMINED THAT THE SHOCKS WERE DUE TO NOISE. THE LEAD WAS CUT, CAPPED, AND REPLACED. NO FURTHER 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 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| L| R | 4196 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |