MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for REPLY REPLY SR manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[183902880]
Reportedly, the pacing system was implanted on (b)(6) 2013. On (b)(6) 2019, it was explanted since pocket infection was observed. The patient was kept under medical supervision and, on (b)(6) 2019, no fever or signs of infection in blood tests were observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00311 |
| MDR Report Key | 9842029 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-12-20 |
| Date Facility Aware | 2019-12-25 |
| Date Mfgr Received | 2019-12-25 |
| Device Manufacturer Date | 2013-09-06 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | REPLY SR |
| Catalog Number | REPLY SR |
| Lot Number | 2748 |
| Device Expiration Date | 2015-04-06 |
| 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 | 2020-03-17 |