InjuryGZE
*
Received Jun 23, 1997 · Event occurred Jun 11, 1997
Report 99918 · MDR key 99918
Device
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.