FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 7869469
·
Received September 12, 2018
Report
- Report Number
- 2649622-2018-14963
- Event Type
- Malfunction
- Date Received
- September 12, 2018
- Date of Event
- August 20, 2018
- Report Date
- September 12, 2018
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00613994446343
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT(S): A 5076 IMPLANTED: (B)(6) 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO POSSIBLE UNDERSENSING AND OVERSENSING. THE RV 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 |
|---|---|---|---|---|---|---|---|
| 710313 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693558 | 00613994446343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |