MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for ATRIAL J 4271 manufactured by Boston Scientific Corporation.
[185774589]
It was reported that this right atrial (ra) lead exhibited low out-of-range (oor) pacing impedances, measuring 200 ohms. It was noted the impedances had consistently ranged between 200 ohms to 300 ohms. The device was reprogrammed to pace and sense in only the ventricle. This ra lead remains in service. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-03106 |
| MDR Report Key | 9901583 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-03-30 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | HISTORICAL PUERTO RICO |
| Manufacturer Street | GUIDANT PUERTO RICO B. V. #12, RD. #698 |
| Manufacturer City | DORADO 00646 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00646 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRIAL J |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Model Number | 4271 |
| Catalog Number | 4271 |
| Device Expiration Date | 2001-01-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |