FDA Adverse Event
Injury
Summary report: N
PARADYM
MDR report key: 1971465
·
Received January 21, 2011
Report
- Report Number
- 1000165971-2011-00033
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 6, 2011
- Manufacturer
- SORIN BIOMEDICA C.R.M., S.R.L.
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED ON (B)(6) 2010 AND AN ISOLINE LEAD WAS CONNECTED TO THE ICD (B)(4). REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE HE RECEIVED 80 SHOCKS THERAPY. PRELIMINARY ANALYSIS REVEALED THAT THE PATTERN OF MOST OF THE RECORDED EPISODES CLEARLY SUGGESTED A LEAD ISSUE (DISLODGEMENT, INSULATION FAILURE, CONDUCTOR FRACTURE). BECAUSE OF THE HIGH FREQUENCY OF THIS PHENOMENON, EVALUATION OF A RE-INTERVENTION WAS RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADYM | MRM | SORIN BIOMEDICA C.R.M., S.R.L. | PARADYM DR 8550 | 2400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |