FDA Adverse Event
Death
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3002453
·
Received March 13, 2013
Report
- Report Number
- 2649622-2013-02524
- Event Type
- Death
- Date Received
- March 13, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 11, 2013
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 PRODUCT: 5076 IMPLANTABLE PACING LEAD 2013 (B)(6). (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT CODED AND DIED AFTER THE IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO VENTRICULAR FIBRILLATION ARREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105063 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Death | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |