FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4162993
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12535
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 5, 2014
- Report Date
- August 5, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS RISING, AND THERE WAS A LEAD IMPEDANCE OUT OF RANGE ALERT.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALARM OCCURRED FOR INCREASED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL IMPEDANCE, WHICH HAD GRADUALLY INCREASED OVER THE LAST 15 DAYS. A CHEST X-RAY WAS PENDING AND THE LEAD REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 639614 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00025 YR | D284VRC ICD |