FDA Adverse Event
Injury
Summary report: N
ISOLINE
MDR report key: 2850543
·
Received November 16, 2012
Report
- Report Number
- 1000165971-2012-00447
- Event Type
- Injury
- Date Received
- November 16, 2012
- Date of Event
- October 31, 2012
- Report Date
- November 9, 2012
- Manufacturer
- SORIN C.R.M.
- Product Code
- MRM
- PMA / PMN Number
- #REF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT DURING A F/U VISIT RELATIVE TO THE SUBJECT DEVICE, SEVERAL TREATED VENTRICULAR FIBRILLATION EPISODES WERE STORED WITHIN THE ASSOCIATED ICD'S MEMORY. THE ICD DIAGNOSED NOISE WITHIN THE VENTRICULAR CHANNEL AS TACHYCARDIA. SHOCKS WERE NOT DELIVERED TO THE PT DUE TO AN OVERLOAD CONDITION. A RE-INTERVENTION WAS PERFORMED TO REPLACE THE SUBJECT LEAD. IT WAS INDICATED THAT THE INSULATION OF THE LEAD WAS SIGNIFICANTLY DAMAGED "BEFORE THE IS-1 CONNECTOR", AND THAT THE PHYSICIAN DID NOT DAMAGE THE LEAD DURING THE PROCEDURE. ONLY THE CONNECTOR SECTION OF THE SUBJECT LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOLINE | #REF | MRM | SORIN C.R.M. | ISOLINE 2CT6 | 2265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |