FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S MRI SURESCAN
MDR report key: 8663587
·
Received June 3, 2019
Report
- Report Number
- 2649622-2019-09461
- Event Type
- Malfunction
- Date Received
- June 3, 2019
- Date of Event
- May 14, 2019
- Report Date
- June 3, 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 LEAD INTEGRITY ALERT (LIA) TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASED NUMBER OF SHORT V-V INTERVALS. OVERSENSING WAS OBSERVED ON STORED ELECTROGRAMS. 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 |
|---|---|---|---|---|---|---|---|
| 456608 | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M62 | 00643169356566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | DVFB1D4 ICD |