MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-09 for ISOLINE ISOLINE 2CR6 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[182564965]
Reportedly during a follow up performed on 14 nov 2019 it was noted that an appropriate shock therapy was delivered following a vf episode on (b)(6) 2019. When measuring the ventricular lead impedance, it increased from 700 ohm to 1232 ohm. When measuring the rv and svc coil impedances, both increased from 500-600 ohm to over 1000 ohm. The data showed that the impedance of both coils seemed to increase just after the date the shock therapy was conducted. The data showed that the atrial impedance was around 200 ohm. No episodes of noise were observed and no anomaly was found in a real time egm. The system remained implanted without any changes in the settings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00290 |
| MDR Report Key | 9805199 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-11-14 |
| Date Facility Aware | 2019-11-15 |
| Date Mfgr Received | 2019-11-15 |
| Device Manufacturer Date | 2011-01-05 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA OUAKI |
| Manufacturer Street | VIA CRESCENTINO S.N. . |
| Manufacturer City | SALUGGIA 13040 |
| Manufacturer Country | IT |
| Manufacturer Postal | 13040 |
| Manufacturer Phone | 146013429 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY |
| Manufacturer Street | VIA CRESCENTINO S.N. . |
| Manufacturer City | SALUGGIA 13040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 13040 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0928-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOLINE |
| Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Product Code | MRM |
| Date Received | 2020-03-09 |
| Model Number | ISOLINE 2CR6 |
| Catalog Number | ISOLINE 2CR6 |
| Lot Number | 2502 |
| Device Expiration Date | 2013-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Manufacturer Address | VIA CRESCENTINO S.N. . SALUGGIA 13040 IT 13040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |