ELA 7034 DDDR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-29 for ELA 7034 DDDR * manufactured by Ela Medical.

Event Text Entries

[243816] Revision of pacemaker (l) chest. Pre-op dx: malfunctioning pacemaker. Generator, atrial and ventricular leads explanted.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 349300
• MDR Report Key: 349300
• Date Received: 2001-08-29
• Date of Report: 2001-08-29
• Date of Event: 2001-08-03
• Date Facility Aware: 2001-08-03
• Report Date: 2001-08-29
• Date Reported to FDA: 2001-08-29
• Date Reported to Mfgr: 2001-08-29
• Date Added to Maude: 2001-08-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ELA
• Generic Name: DDDR
• Product Code: DXR
• Date Received: 2001-08-29
• Model Number: 7034 DDDR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 338617
• Manufacturer: ELA MEDICAL
• Manufacturer Address: 15245 MINNETONKA RD MINNETONKA MN 553451510 US

Device Sequence Number: 2

• Brand Name: ELA
• Generic Name: ATRIAL LEAD
• Product Code: DXR
• Date Received: 2001-08-29
• Model Number: BIM25920
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 338619
• Manufacturer: ELA MEDICAL
• Manufacturer Address: 15245 MINNETONKA RD MINNETONKA MN 553451510 US

Device Sequence Number: 3

• Brand Name: ELA
• Generic Name: VENT LEAD
• Product Code: DXR
• Date Received: 2001-08-29
• Model Number: 98BT462782
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 338620
• Manufacturer: ELA MEDICAL
• Manufacturer Address: 15245 MINNETONKA RD MINNETONKA MN 553451510 US

Device Sequence Number: 4

• Brand Name: *
• Date Received: 2001-08-29
• Implant Flag: N
• Device Sequence No: 4
• Device Event Key: 338995

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-08-29