MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for SYMPHONY RHAPSODY D 2410 manufactured by Sorin Crm.
[112726025]
The device model involved in this mdr 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
[112726026]
This device was explanted on (b)(6) 2018 during the autopsy of the patient who died a few days ago due to unknown causes (it seems the patient was swimming at the time of death). During the interrogation of this explanted device as requested by the physician, the pm reported operating modes with nominal parameters for battery discharge and consequent unavailability of data in memory. The user requests to recover the residual data from the pm's memory to complete the ongoing legal medical checks. This device will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2018-00612 |
| MDR Report Key | 7640957 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-06-07 |
| Date Facility Aware | 2018-06-07 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2007-06-27 |
| Date Added to Maude | 2018-06-27 |
| 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 | PARC D'AFFAIRES NOVEOS 4 AVENUE R . |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 0146013665 |
| Manufacturer G1 | SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE |
| 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 | 0 |
| Brand Name | SYMPHONY |
| Generic Name | DUAL-CHAMBER PACEMAKER, DEMAND |
| Product Code | OVJ |
| Date Received | 2018-06-27 |
| Returned To Mfg | 2018-06-18 |
| Model Number | RHAPSODY D 2410 |
| Catalog Number | RHAPSODY D 2410 |
| Lot Number | S070713 |
| Device Expiration Date | 2009-01-27 |
| 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 CRM |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-27 |