SPRINT QUATTRO
Report
- Report Number
- 2649622-2012-14814
- Event Type
- Injury
- Date Received
- October 15, 2012
- Report Date
- November 27, 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
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.
PRODUCT EVENT SUMMARY: (B)(4): PERFORMANCE INFORMATION WAS RETRIEVED FROM THE DEVICE, AND HAS BEEN ANALYZED. IMPEDANCE/HIGH IMPEDANCE: 1 - PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 09:00:10. DAILY PACE IMPEDANCE TREND DATA SHOWS AN INCREASE FOR VENTRICULAR PACE BI IMPEDANCE= 950 TO 4047 OHMS PEAK BETWEEN (B)(6) 2012. SENSING/OVERSENSING: VENTRICULAR SHORT INTERVAL COUNT V-SIC=4171 COUNTS, IN 3.48 DAYS, BETWEEN (B)(6) 2012. ALERTS: 2 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 SENSING/NOISE: 15 - VENTRICULAR NST<(><<)>=210MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 17:28:51 AND 17:34:32. 26 - VF<(><<)>=210 MS AVERAGE V-CYCLE ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 03:37:33 AND 17:10:14.
IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO RECEIVING SEVERAL SHOCKS. DURING THE LEAD REVISION, THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH IMPEDANCE. WHILE EXTRACTING THE LEAD, IT WAS "JAMMED" AND THE LEAD REMAINED IMPLANTED. LATER, THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO RECEIVING SEVERAL SHOCKS. DURING THE LEAD REVISION, THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH IMPEDANCE. WHILE EXTRACTING THE LEAD, IT WAS "JAMMED" AND THE LEAD REMAINED IMPLANTED. LATER, THE LEAD WAS EXPLANTED 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 | 66 YR | Hospitalization| L| R | 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |