MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-26 for ISOLINE ISOLINE 2CR6 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[181541639]
The subject defibrillation lead was implanted on (b)(6) 2009 and connected to a replacement icd on 13 april 2016. Reportedly, during a follow-up performed on (b)(6) 2020, an issue at the level of the defibrillation lead, with low detection and sensitivity, was observed. Since a lead issue was suspected, a re-intervention was performed the next day. The defibrillation lead was abandoned in the patient? S body and a new one was implanted. Based on preliminary analysis, a defibrillation lead issue is suspected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00277 |
| MDR Report Key | 9756498 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-04 |
| Date Facility Aware | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Model Number | ISOLINE 2CR6 |
| Catalog Number | ISOLINE 2CR6 |
| 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 | 2020-02-26 |