MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-13 for PLATINIUM PLATINIUM VR 1240 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[182001472]
The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
Patient Sequence No: 1, Text Type: N, H10
[182001473]
Reportedly, in (b)(6) 2019, the patient received an appropriate shock following a ventricular fibrillation. The icd was checked two days later and normal functioning was observed. Two days after, the patient reported a bruise on the skin around the device. The week after, the doctor of the patient indicated that it was not a bruise but a burn from the shock. The patient reported that the skin was bruised on the shoulder with the shape of the icd and it was maybe a little warm. On (b)(6) 2020, more than four months after the shock, the patient had a routine follow-up with the cardiologist. The bruise was still present but had a smaller size and was still painful. The cardiologist excluded the possibility of a burn from the icd as the bruise appeared four days after the shock. However, an infection is suspected and some tests will be performed. Preliminary analysis showed that the subject device has been sterilized and released according to all applicable procedures and revealed some episodes of ventricular noise oversensing stored in the device memory, most probably resulting from electromagnetic interferences (emi) and/or myopotentials.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00256 |
| MDR Report Key | 9705687 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-04-01 |
| Date of Event | 2019-09-07 |
| Date Facility Aware | 2020-01-21 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2020-02-13 |
| 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 | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 146013429 |
| Manufacturer G1 | SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATINIUM |
| Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Product Code | MRM |
| Date Received | 2020-02-13 |
| Model Number | PLATINIUM VR 1240 |
| Catalog Number | PLATINIUM VR 1240 |
| Lot Number | S0293 |
| Device Expiration Date | 2019-06-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |