UFM O 26MM 1/2 89MM KN 24PK BX
Received Jun 15, 2026 · Event occurred Jun 3, 2026
Report 0002242056-2026-00008 · MDR key 25503485
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
A&e Medical CorporationCatalog number
025-200
Lot number
29665
Product problems
- Installation-Related Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4). G2 - REPORT SOURCE - FOREIGN - FINLAND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS: HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE DEVICE WAS IMPLANTED AND DURING TESTING, AN UNKNOWN COMPLICATION OCCURRED WHICH CAUSED UNKNOWN INJURIES TO THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.