FDA Adverse Event
Injury
Summary report: N
OVATIO
MDR report key: 2241634
·
Received September 9, 2011
Report
- Report Number
- 2182863-2011-00081
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 11, 2011
- Manufacturer
- SORIN CRM S.A.S.
- Product Code
- MRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING.
Additional Manufacturer Narrative · 1
THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4).
Description of Event or Problem · 1
THIS ICD WAS EXPLANTED BECAUSE THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO A LEAD FRACTURE. IT WAS REPORTED THAT THERE WAS INAPPROPRIATE SENSING THAT LEAD TO A SHOCK. A NEW PARADYM AND ST. JUDE LEAD WERE IMPLANTED. NOTE: THE ISOLINE LEAD THAT WAS CONNECTED TO THIS ICD WAS ALSO RETURNED AND REPORTED ON AN MDR.
Description of Event or Problem · 1
THIS ICD WAS EXPLANTED BECAUSE THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO A LEAD FRACTURE. IT WAS REPORTED THAT THERE WAS INAPPROPRIATE SENSING THAT LEAD TO A SHOCK. A NEW PARADYM AND ST. JUDE LEAD WERE IMPLANTED. NOTE: THE ISOLINE LEAD THAT WAS CONNECTED TO THIS ICD WAS ALSO RETURNED AND REPORTED ON AN MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVATIO | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | MRM | SORIN CRM S.A.S. | 6550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |