inforMED
InjuryGZE

*

Received Jun 23, 1997 · Event occurred Jun 11, 1997

Report 99918 · MDR key 99918

Device

Generic name

*

Manufacturer

Atrotechoy

Model number

FE4BR

Catalog number

FL3

Lot number

0496

Patient

5 YR

  • Surgical procedure

Narrative

Description of Event or Problem

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.