FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4161146
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11621
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- June 3, 2014
- Report Date
- July 15, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- 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 MEDICAL PRODUCTS: A 5076-45 LEAD, IMPLANTED (B)(6) 2012. A 419588 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN LEAD INTEGRITY ALERT (LIA) DUE TO OVERSENSING OF ELECTROMAGNETIC INTERFERENCE (EMI). THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 637926 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Life Threatening | D224TRK ICD |