MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-21 for PARADYM RF PARADYM RF VR 9250 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[180317643]
The device 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
[180317644]
The defibrillation system was implanted on (b)(6) 2015. Reportedly, therapies were delivered so the patient went to the hospital on (b)(6) 2019 for a review, which revealed noise oversensing. The electrode was checked with fluoroscopy and no damage was observed. The physician decided to deactivate atp and shock therapies to monitor the patient. A follow-up was scheduled for (b)(6) 2020. On (b)(6) 2020, the defibrillation system was explanted and should be returned for analysis. During the procedure, it was not possible to explant the lead by using a stylet and retracting the helix. Therefore, the lead was explanted using another system. The physician reported that the damage on the external coil was due to the extraction maneuvers, however the filament on the proximal coil was not caused by the procedure. Preliminary analysis revealed that the noise oversensing was most probably due to a ventricular lead issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00231 |
| MDR Report Key | 9611285 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-21 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-23 |
| Date Facility Aware | 2019-12-27 |
| Date Mfgr Received | 2020-03-22 |
| Device Manufacturer Date | 2015-01-16 |
| Date Added to Maude | 2020-01-21 |
| 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 | PARADYM RF |
| Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
| Product Code | MRM |
| Date Received | 2020-01-21 |
| Returned To Mfg | 2020-01-29 |
| Model Number | PARADYM RF VR 9250 |
| Catalog Number | PARADYM RF VR 9250 |
| Lot Number | S0063 |
| Device Expiration Date | 2016-02-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-21 |