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 CAPSUREFIX NOVUS LEAD MRI SURESCAN 5076-58 manufactured by Medtronic Singapore Operations.
[185773430]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185773431]
It was reported that the patient experienced bradycardia. It was also reported that the right ventricular (rv) lead exhibited intermittent undersensing on stored electrograms (egm). The lead remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008973940-2020-00773 |
| MDR Report Key | 9902791 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2016-09-26 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC SINGAPORE OPERATIONS |
| Manufacturer Street | 49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE |
| Manufacturer City | SINGAPORE 486056 |
| Manufacturer Country | SG |
| Manufacturer Postal Code | 486056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPSUREFIX NOVUS LEAD MRI SURESCAN |
| Generic Name | ELECTRODE, PACEMAKER, PERMANENT |
| Product Code | DTB |
| Date Received | 2020-03-31 |
| Model Number | 5076-58 |
| Catalog Number | 5076-58 |
| Device Expiration Date | 2018-09-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SINGAPORE OPERATIONS |
| Manufacturer Address | 49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE SINGAPORE 486056 SG 486056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5867 | 2020-03-31 |