MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-31 for MEDTRONIC ICD MDT-ICD manufactured by Medtronic, Inc..
[185781700]
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. Patient information is limited due to confidentiality concerns. The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers. The model listed in the report is a representative of the model family, as there is no specific model numbers listed. Possible models could include: viva, protecta, consulta, claria mri quad, amplia mri quad. Since no device id was provided, it is unknown if this event has been previously reported. The exact cause and date of death is not available at the time of this report; as there is no indication of specific serial number for patient information. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article:? Efficacy of a device-based continuous optimization algorithm for patients with cardiac resynchronization therapy.? Circulation journal. 2019;84(1):18-25. Doi: 10. 1253/circj. Cj-19-0691. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185781701]
A journal article was reviewed which contained information regarding cardiac resynchronization therapy (crt) devices. The article reports there were patient deaths; however, there was no indication that the deaths were device related. The medical history of the patients involved indicate that there is a greater propensity for patient mortality. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers. The status /location of the device is unknown. The cause of death has been requested, but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00635 |
| MDR Report Key | 9905417 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-10-26 |
| Date Mfgr Received | 2020-03-16 |
| 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, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC ICD |
| Generic Name | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE |
| Product Code | DXY |
| Date Received | 2020-03-31 |
| Model Number | MDT-ICD |
| Catalog Number | MDT-ICD |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-31 |