FDA Adverse Event
Death
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 5080070
·
Received September 16, 2015
Report
- Report Number
- 3010215456-2015-29205
- Event Type
- Death
- Date Received
- September 16, 2015
- Date of Event
- August 29, 2015
- Report Date
- September 8, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC. (CRM-KISTA)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ON A VF EPISODE THE DEVICE DID NOT DELIVER HIGH VOLTAGE THERAPY DUE TO AN ABNORMAL IMPEDANCE OF THE LEAD. THE VF EPISODE CONTINUED. THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION BUT EXPIRED, AFTER CEPHALIC DEATH WAS NOTED, ON (B)(6) 2015. THE LEAD REMAINED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613197 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC. (CRM-KISTA) | 1580/65 | 2912359 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |