FDA Adverse Event
Death
Summary report: N
DD+ MECHANICAL QUAL DEVICE
MDR report key: 6132106
·
Received November 29, 2016
Report
- Report Number
- 2938836-2016-14909
- Event Type
- Death
- Date Received
- November 29, 2016
- Date of Event
- November 1, 2016
- Report Date
- November 1, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOLLOWING ORTHOPEDIC SURGERY AND EXPIRED WHILE ASLEEP. THE DEVICE UNDERSENSED VF EPISODE, FAILED TO DELIVER THERAPY AND ULTIMATELY RESULTED IN PATIENT DEATH. UPON REVIEW OF THE SESSION RECORD, THERE IS SOME VENTRICULAR UNDERSENSING DURING THE EPISODES. THE UNDERSENSED SIGNALS ARE VERY SMALL AND ARE FOLLOWING LARGER SIGNALS SO THE SENSING IS NOT ADAPTED FAST ENOUGH. VF DETECTION IS PROGRAMMED TO 25 INTERVALS WHICH DELAYS THE VF DIAGNOSIS. NO OTHER ANOMALIES WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782116 | DD+ MECHANICAL QUAL DEVICE | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2259-40 | 3804690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | (B)(4) |