MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for REPLY REPLY DR manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[184349460]
Reportedly, on (b)(6) 2020, the patient came to the hospital due to malaise and presented a ventricular fibrillation. The physician would like to know if there is a link between the pacemaker functioning and the ventricular fibrillation. Four external shocks were delivered to the patient around 08h20. There is an interruption in the atrial lead curve around this timing, but the pacemaker seems to work well. Preliminary analysis revealed normal pacemaker functioning before and after the reported external shocks and confirmed the reported ventricular fibrillation (vf). Moreover, undersensing of the vf was observed, most probably due to the programmed ventricular sensitivity (2. 5 mv). In addition, external shocks delivery might have altered transitively the functioning of some of the electronic components of the device, which could have also influenced the sensing capability of the device during the shocks delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00319 |
| MDR Report Key | 9861601 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-26 |
| Date Facility Aware | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2013-01-31 |
| Date Added to Maude | 2020-03-20 |
| 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 | REPLY |
| Generic Name | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
| Product Code | DXY |
| Date Received | 2020-03-20 |
| Model Number | REPLY DR |
| Catalog Number | REPLY DR |
| Lot Number | 2682 |
| Device Expiration Date | 2014-08-31 |
| 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 | 1. Required No Informationntervention | 2020-03-20 |