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 SELECTSECURE MRI SURESCAN 383059 manufactured by Mpri.
[186095300]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186095301]
It was reported that the right atrial (ra) lead dislodged. The lead was explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188288915]
Product event summary: the full lead was returned, analyzed, and no anomalies were found. The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth. Visual analysis of the lead indicated apparent explant damage. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2649622-2020-06658 |
MDR Report Key | 9902892 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-31 |
Date of Report | 2020-03-31 |
Date Mfgr Received | 2020-03-09 |
Device Manufacturer Date | 2019-11-26 |
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 | 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 | SELECTSECURE MRI SURESCAN |
Generic Name | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE |
Product Code | NVN |
Date Received | 2020-03-31 |
Returned To Mfg | 2020-03-16 |
Model Number | 383059 |
Catalog Number | 383059 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | N |
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 |