FDA Adverse Event
Malfunction
Summary report: N
PARADYM
MDR report key: 2062751
·
Received April 19, 2011
Report
- Report Number
- 2182863-2011-00032
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 23, 2011
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APRIL 19, 2011. THE ANALYSIS FROM THE MANUFACTURER IS PENDING.
Additional Manufacturer Narrative · 1
(B)(6) 2011. THE ANALYSIS FROM THE MANUFACTURER IS PENDING. (B)(6) 2011 (B)(4).
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, ONCE THE PATIENT WAS INDUCED INTO VF, THE DEVICE DID NOT DELIVER THERAPY. IT WAS REPORTED THAT THE INDUCED RHYTHM WAS PROBABLY BELOW THE LOWEST TACHY ZONE. THE DEVICE WAS NOT IMPLANTED, A COMPETITOR'S DEVICE WAS IMPLANTED INSTEAD.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, ONCE THE PATIENT WAS INDUCED INTO VF, THE DEVICE DID NOT DELIVER THERAPY. IT WAS REPORTED THAT THE INDUCED RHYTHM WAS PROBABLY BELOW THE LOWEST TACHY ZONE. THE DEVICE WAS NOT IMPLANTED, A COMPETITOR'S DEVICE WAS IMPLANTED INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | SORIN BIOMEDICA CRM S.R.L. | 8550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |