FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3992998
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09562
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 3, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT: D224DRG ICD IMPLANTED: 2009-(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LARGE NUMBER OF SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR LEAD. THERE WERE NO EPISODES. ISOMETRICS DID NOT PRODUCE ANY SIC. 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 |
|---|---|---|---|---|---|---|---|
| 468115 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | 5076-52 LEAD |