MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-06 for REPLY REPLY VDR manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[27933922]
The device model 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
[27933923]
On (b)(6) 2015, on a follow-up performed on a patient with background of atrial fibrillation, all the measurements were normal. In order to promote the spontaneous rhythm, different atrio ventricular (av) intervals were programmed and the patient started to feel bad. When programming the av interval to 230/170 with a frequency of 50 min-1, according to the physician, when clicking on the "program" button, the programmer head was moved from the correct position and then telemetry was lost. At that moment the patient suffered a heart failure with loss of sphincter muscle control and a cardiac resuscitation was needed. The patient recovered especially when vvi mode at 80min-1 was programmed. Preliminary analysis showed that retrograde (va) conduction was observed within the follow-up. This may have been caused by the application of asynchronous modes during the tests performed within the follow-up and/or modifications of timing parameters (rates and/or avd) as reported and confirmed through files analysis. The retrograde conduction was not observed anymore at the end of the follow-up.
Patient Sequence No: 1, Text Type: D, B5
[33717195]
Patient Sequence No: 1, Text Type: N, H10
[33717196]
On september 16th, 2015, on a follow-up performed on a patient with background of atrial fibrillation, all the measurements were normal. In order to promote the spontaneous rhythm, different atrio ventricular (av) intervals were programmed and the patient started to feel bad. When programming the av interval to 230/170 with a frequency of 50 min-1, according to the physician, when clicking on the? Program? Button, the programmer head was moved from the correct position and then telemetry was lost. At that moment, the patient suffered a heart failure with loss of sphincter muscle control and a cardiac resuscitation was needed. The patient recovered especially when vvi mode at 80min-1 was programmed. Preliminary analysis showed that retrograde (va) conduction was observed within the follow-up. This may have been caused by the application of asynchronous modes during the tests performed within the follow-up and/or modifications of timing parameters (rates and/or avd) as reported and confirmed through files analysis. The retrograde conduction was not observed anymore at the end of the follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2015-00590 |
| MDR Report Key | 5130362 |
| Date Received | 2015-10-06 |
| Date of Report | 2015-09-16 |
| Date of Event | 2015-09-16 |
| Date Facility Aware | 2015-09-16 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2013-03-07 |
| Date Added to Maude | 2015-10-06 |
| 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 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 |
| Product Code | CEO |
| Date Received | 2015-10-06 |
| Model Number | REPLY VDR |
| Catalog Number | REPLY VDR |
| Lot Number | 2693 |
| Device Expiration Date | 2014-10-07 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-10-06 |