FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 8425322
·
Received March 15, 2019
Report
- Report Number
- 2649622-2019-04450
- Event Type
- Malfunction
- Date Received
- March 15, 2019
- Date of Event
- February 19, 2019
- Report Date
- March 15, 2019
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00643169356566
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SHORT V-V INTERVALS, AND HIGH RATE NON-SUSTAINED EPISODES. AS WELL, THERE WAS UNDERSENSING. 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 |
|---|---|---|---|---|---|---|---|
| 217085 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M62 | 00643169356566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | DTMB1QQ CRTD, 5076 LEAD, 4298 LEAD |