FDA Adverse Event
Injury
Summary report: N
ISOLINE
MDR report key: 3012576
·
Received March 15, 2013
Report
- Report Number
- 1000165971-2013-00147
- Event Type
- Injury
- Date Received
- March 15, 2013
- Date of Event
- February 18, 2013
- Report Date
- March 12, 2013
- Manufacturer
- SORIN CRM S.R.L.
- Product Code
- MRM
- PMA / PMN Number
- P980049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 PENDING.
Description of Event or Problem · 1
OVERSENSING AND PACING INHIBITION RELATIVE TO THE SUBJECT LEAD WAS REPORTED. THE CRT-D SYSTEM REMAINS IMPLANTED. THE REPORTED BIPOLAR LEAD IMPEDANCE OF THE SUBJECT LEAD WAS 554 OHMS. THE SUBJECT LEAD IS ASSOCIATED TO THE FOLLOWING SORIN BRAND DEVICES: OVATIO 6750, SN (B)(4) AND SITUS OTW UW28D LV LEAD, SN (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110096 | ISOLINE | MRM | SORIN CRM S.R.L. | ISOLINE 2CR6 | 2214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |