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 2019-10-23 for MELODY TRANSCATHER PULMONARY PB10F18 manufactured by Medtronic Heart Valves Division.
[163765197]
The device remains implanted; therefore, no product analysis can be performed. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[163765198]
Medtronic received information that nine years, six months and seven days following the implant of this 18mm transcatheter pulmonary bioprosthetic valve, a balloon angioplasty was performed on the stenotic melody valve. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2025587-2019-03249 |
MDR Report Key | 9226771 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-10-23 |
Date of Report | 2019-10-23 |
Date of Event | 2017-02-21 |
Date Mfgr Received | 2019-10-03 |
Date Added to Maude | 2019-10-23 |
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 STREET NE |
Manufacturer City | MOUNDS VIEW MN 55112 |
Manufacturer Country | US |
Manufacturer Postal | 55112 |
Manufacturer Phone | 7635055378 |
Manufacturer G1 | MEDTRONIC HEART VALVES DIVISION |
Manufacturer Street | 1851 E DEERE AVE |
Manufacturer City | SANTA ANA CA 92705 |
Manufacturer Country | US |
Manufacturer Postal Code | 92705 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MELODY TRANSCATHER PULMONARY |
Generic Name | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED |
Product Code | NPV |
Date Received | 2019-10-23 |
Model Number | PB10F18 |
Catalog Number | PB10F18 |
Lot Number | NA |
Device Expiration Date | 2008-04-05 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC HEART VALVES DIVISION |
Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-10-23 |