MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for CAPSUREFIX NOVUS LEAD MRI SURESCAN 5076-58 manufactured by Medtronic Singapore Operations.
[185773935]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185773936]
It was reported that the right ventricular (rv) lead exhibited a high number of sensing integrity counter (sic) events, varying r waves and low r waves. The rv lead remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188939808]
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter. Analysis of the device memory indicated an r-wave amplitude measurement issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008973940-2020-00774 |
| MDR Report Key | 9902938 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2017-02-09 |
| 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 | 2019-01-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 0 | 2020-03-31 |