FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4162478
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12755
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 20, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
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: 694758 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A ROUTINE DEVICE CHANGE OUT, DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WITH THE REPLACEMENT DEVICE. DUE TO A MALFUNCTION OF THE CHRONIC RIGHT VENTRICULAR (RV) LEAD, THE DFT FAILED TO SHOCK AND DELIVERED LESS ENERGY AND LOW IMPEDANCE. THE CHRONIC RV LEAD WAS CAPPED AND A REPLACEMENT RV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640027 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR | Hospitalization| R | DVBB1D1 ICD |