FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 8222492
·
Received January 7, 2019
Report
- Report Number
- 2649622-2019-00263
- Event Type
- Injury
- Date Received
- January 7, 2019
- Date of Event
- December 9, 2018
- Report Date
- January 7, 2019
- Manufacturer
- MPRI
- Product Code
- LWS
- UDI-DI
- 00613994249890
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
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 RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH BIPOLAR IMPEDANCE MEASUREMENTS AND A POSSIBLE FRACTURE. REPROGRAMMING WAS DONE, AND THE LEAD WAS LATER CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17044 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 | 00613994249890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R | DTBA1Q1 ICD, 6725 ADAPTOR, 459888 LEAD |