* FE4BR FL3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-23 for * FE4BR FL3 manufactured by Atrotechoy.

Event Text Entries

[20142177] The atrostim jukka, an fda provisional device for diaphragmatic pacing, was inserted into this 5 year old child on 11/13/96. On 6/9/97, the child was brought to medical center with signs of left sided pacer failure. On 6/11/97 the child was taken to the or and it was noted that the connecting wire had some "skip lesions" and disintegration of wire.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 99918
• MDR Report Key: 99918
• Date Received: 1997-06-23
• Date of Report: 1997-06-17
• Date of Event: 1997-06-11
• Date Facility Aware: 1997-06-11
• Report Date: 1997-06-17
• Date Reported to FDA: 1997-06-20
• Date Reported to Mfgr: 1997-06-20
• Date Added to Maude: 1997-06-25
• 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
• Reporter Occupation: RISK MANAGER
• 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 Details

• Brand Name: *
• Generic Name: *
• Product Code: GZE
• Date Received: 1997-06-23
• Model Number: FE4BR
• Catalog Number: FL3
• Lot Number: 0496
• ID Number: *
• Device Expiration Date: 1997-11-11
• Device Availability: Y
• Device Age: 7 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 98440
• Manufacturer: ATROTECHOY
• Manufacturer Address: P.O. BOX 28 TEMPERE FI FIN-33721

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	1997-06-23