MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-07 for OPUS OPUS 4024 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[88703886]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88703887]
Reportedly, patient died from unknown causes on (b)(6) 1990. It is unknown whether the device was explanted or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2017-00739 |
| MDR Report Key | 6927210 |
| Date Received | 2017-10-07 |
| Date of Report | 2017-09-08 |
| Date of Event | 1990-03-30 |
| Date Facility Aware | 2017-09-08 |
| Date Mfgr Received | 2017-09-08 |
| Date Added to Maude | 2017-10-07 |
| 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 | ELODIE VINCENT |
| Manufacturer Street | 4 AVENUE R PARC D'AFFAIRES NOVEOS |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL (SALUGGIA ITALY) |
| Manufacturer Street | 4 AVENUE R PARC D'AFFAIRES NOVEOS |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPUS |
| Generic Name | SINGLE-CHAMBER PACEMAKER |
| Product Code | LWW |
| Date Received | 2017-10-07 |
| Model Number | OPUS 4024 |
| Catalog Number | OPUS 4024 |
| 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 | 4 AVENUE R?AUMUR PARC D'AFFAIRES NOVEOS CLAMART, 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-10-07 |