MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for ENO ENO DR manufactured by Microport Crm S.r.l..
[185746101]
The device 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
[185746102]
Reportedly, before being implanted on (b)(6) 2020, the subject pacemaker was programmed in automatic detection of implantation to set the lead pacing polarities to unipolar. Normal impedance values were measured for both leads after the procedure (around 380 ohms). However, no sensing and flat egm were observed. The atrial and ventricular sensing polarities were unexpectedly found programmed in bipolar, though both leads were unipolar. The atrial and ventricular thresholds were similar to those measured with the previous pacemaker. The ventricular threshold was measured at 2. 25 v, but the physician had decided not to replace the ventricular lead as the percentage of ventricular pacing was low. After reducing the atrial and ventricular sensitivities and re-programming both leads sensing polarities to unipolar, normal behavior of the pacemaker was observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00334 |
| MDR Report Key | 9903112 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-06 |
| Date Facility Aware | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-03-31 |
| 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 REAUMUR |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 146013429 |
| Manufacturer G1 | MICROPORT CRM S.R.L. VIA CRESCENTINO 13040 SALUGGIA ITALY |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE REAUMUR |
| 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 | ENO |
| Generic Name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Product Code | LWP |
| Date Received | 2020-03-31 |
| Model Number | ENO DR |
| Catalog Number | ENO DR |
| Lot Number | S0402 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROPORT CRM S.R.L. |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE REAUMUR CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |