MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-25 for ISOLINE ISOLINE 2CR6 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[183908144]
Reportedly, the patient was transported to the hospital by emergency on (b)(6) 2020 because several inappropriate shocks were delivered. Review of the patient files revealed that 30 inappropriate shocks were delivered because of noise oversensing. The ventricular capture threshold was at 1. 5v/0. 35 ms, the r-wave amplitude at 3. 0 ms and the ventricular lead impedance, rv and svc coils continuity measurements were respectively at 356 ohms, 354 ohms and 251 ohms. As a defibrillation lead issue was suspected by the physician, the patient was transferred to another hospital to perform a re-intervention on (b)(6) 2020. The subject defibrillation lead was explanted on (b)(6) 2020 and a new defibrillation system was implanted on the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00274 |
| MDR Report Key | 9750309 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-01 |
| Date Facility Aware | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| 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 | 2020-02-25 |