FDA Adverse Event
Death
Summary report: N
TENDRIL SDX LEAD
MDR report key: 6013809
·
Received October 10, 2016
Report
- Report Number
- 2938836-2016-12203
- Event Type
- Death
- Date Received
- October 10, 2016
- Date of Event
- June 29, 2014
- Report Date
- September 13, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE CAUSE DEATH WAS CONGESTIVE HEART FAILURE (CHF), CEREBRAL INFARCTION AND ARTERIOSCLEROSIS. THE MANNER OF DEATH WAS NATURAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 665121 | TENDRIL SDX LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 1688TC/52 | 2708507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death | (B)(4)| (B)(4)| (B)(4) |