FDA Adverse Event
Injury
Summary report: N
PARADYM
MDR report key: 2771574
·
Received October 4, 2012
Report
- Report Number
- 2182863-2012-00087
- Event Type
- Injury
- Date Received
- October 4, 2012
- Date of Event
- September 14, 2012
- Report Date
- September 17, 2012
- Manufacturer
- SORIN CRM
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2012. A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4). SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS SHOWED THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. (B)(4): DEVICE WAS NOT RETURNED.
Additional Manufacturer Narrative · 1
(B)(4), 2012. A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
AFTER 2-3 WEEKS OF IMPLANTION THIS DEVICE WAS EXPLANTED DUE TO INFECTION.
Description of Event or Problem · 1
AFTER 2-3 WEEKS OF IMPLANTION THIS DEVICE WAS EXPLANTED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | SORIN CRM | 8550 | 2582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |