FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3991546
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08065
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 2, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PRODUCT: 419688 LEAD, IMPLANTED: (B)(6) 2011; 5076-52 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ALERT WAS TRIGGERED DUE TO RIGHT VENTRICULAR (RV) LEAD OVERSENSING FOR SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH LESS THAN 220 MS V-V INTERVALS. THE DOCTOR PLANNED ON REPLACED THE RV LEAD THAT DAY. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. THE RIGHT ATRIAL (RA) 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 |
|---|---|---|---|---|---|---|---|
| 470434 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| R | D224TRK BIV ICD |