MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-04 for PARADYM RF PARADYM RF DR 9550 manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[182002198]
Reportedly, during a follow-up performed on (b)(6) 2020, the following message was displayed: ''[65] technical issue. Rf has been automatically deactivated due to external activations on (b)(6) 2019. Please reactivate it if needed''. The patient had previously reported some communication issues with the associated home monitor. Therefore, it was replaced by another one on (b)(6) 2019. However, the communication issues persisted (patient initiated transfer button lighting in red). Preliminary analysis revealed that the rf was deactivated for this device because the time of communication with the home monitor exceeded the limit time allowed for this action (36 minutes). On (b)(6) 2019, most probably due to the presence of polluters in the environment, or the distance between the implant and the home monitor. The device behaved as specified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00249 |
| MDR Report Key | 9664854 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-03-29 |
| Date Facility Aware | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2013-02-26 |
| Date Added to Maude | 2020-02-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-02-04 |
| Model Number | PARADYM RF DR 9550 |
| Catalog Number | PARADYM RF DR 9550 |
| Lot Number | 2691 |
| Device Expiration Date | 2014-03-26 |
| 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 | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |