MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for CAPSURE EPICARDIAL LEAD 4968-35 manufactured by Mpri.
[185751034]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185751035]
It was reported that over-sensing noise was noted on both the right atrial (ra) lead and the left ventricular (lv) leads. It was also reported that there was high number of the sensing integrity counter (sic) oversensing episodes on both leads. Both leads remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186455591]
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 associated with the right ventricular lead. Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met. Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186455592]
It was further reported that a revision has been scheduled for a transvenous system to be implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2020-06688 |
| MDR Report Key | 9903381 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-03 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2017-07-24 |
| 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 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPSURE EPICARDIAL LEAD |
| Generic Name | ELECTRODE, PACEMAKER, PERMANENT |
| Product Code | DTB |
| Date Received | 2020-03-31 |
| Model Number | 4968-35 |
| Catalog Number | 4968-35 |
| Device Expiration Date | 2019-07-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |