SPRINT QUATTRO
Report
- Report Number
- 2649622-2010-06937
- Event Type
- Malfunction
- Date Received
- August 10, 2010
- Date of Event
- June 29, 2010
- Report Date
- October 5, 2018
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 4 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2008 AND (B)(6) 2009. WEEKLY PACE LEAD IMPEDANCE TREND DATA IN (B)(4) SHOWS HIGH IMPEDANCE OVER THE RANGE FOR MAX RV PACE = 2880 TO 3392 PEAK OHMS, BETWEEN (B)(6) 2009 AND (B)(6) 2011.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A CALL WAS RECEIVED THROUGH TECHNICAL SERVICES REPORTING IMPEDANCE VALUES OF > 3000 OHMS WERE NOTED. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES INCREASING IMPEDANCES OVER TIME, FROM AN INITIAL BASELINE OF 600-700 OHMS. CAPTURE THRESHOLDS AND SENSING HAVE BEEN AFFECTED. IT WAS REPORTED THAT IMPEDANCES HAD RISEN FROM 600-700 RANGE TO 2208 OHMS IN THE PREVIOUS YEAR. CAPTURE AND SENSING WERE BOTH AFFECTED: CAPTURE THRESHOLD INCREASED AND SENSING [R-WAVES] WERE DIMINISHED. HIGH VOLTAGE LEAD IMPEDANCES WERE ALSO RISING. AT 11 MONTHS LATER IT WAS REPORTED THAT CHRONIC IMPEDANCE RISE WAS CONTINUING, WITH RECENT IMPEDANCES BETWEEN 2320 - 2608 OHMS, AND OVERSENSING WAS NOTED IN DEVICE RECORDINGS. IT WAS LATER REPORTED THAT IMPEDANCE IS GREATER THAN 3000 OHMS AND THAT THE PACING/SENSING SITUATION CONTINUES TO BE MONITORED. IT WAS FURTHER REPORTED THAT THERE WAS T-WAVE OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
A CALL WAS RECEIVED THROUGH TECHNICAL SERVICES REPORTING IMPEDANCE VALUES OF > 3000 OHMS WERE NOTED. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES INCREASING IMPEDANCES OVER TIME, FROM AN INITIAL BASELINE OF 600-700 OHMS. CAPTURE THRESHOLDS AND SENSING HAVE BEEN AFFECTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED WITH NO REPORTED ALLEGATIONS. THE REMAINS OF THE LEAD IS STILL IN USE. 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 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |