MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-16 for MEDTRONIC LEAD MDT-LEAD manufactured by Medtronic, Inc..
[183924124]
This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. Of note, multiple patients were noted in the article; and a one to one correlation could not be made with unique device serial numbers. The average age was 24 years old. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: frequency of cied remote monitoring: a quality improvement follow-up study pace - pacing and clinical electrophysiology 2019;42:959? 962 doi: 10. 1111/pace. 13707. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183924125]
A journal article was reviewed that contained information regarding cardiovascular implantable electronic device (cied) and leads. The authors conducted a retrospective cohort follow up study which showed there were device and lead malfunctions that were actionable events to include revision. Additionally, there were cases of arrhythmia. The disposition of the devices/leads is not known. Further follow up did not yet yield and additional information. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00507 |
| MDR Report Key | 9837206 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-16 |
| 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 LEAD |
| Generic Name | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE |
| Product Code | DXY |
| Date Received | 2020-03-16 |
| Model Number | MDT-LEAD |
| Catalog Number | MDT-LEAD |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-16 |