FDA Adverse Event Injury Summary report: N

HIRES 90K

MDR report key: 1353028 · Received March 26, 2009

Report

Report Number: 3006556115-2009-00170
Event Type: Injury
Date Received: March 26, 2009
Date of Event: February 3, 2006
Report Date: March 16, 2009
Manufacturer: ADVANCED BIONICS CORPORATION
Product Code: MCM
PMA / PMN Number: P960058
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. AT THE TIME OF THE PATIENT'S DISCHARGE FROM THE HOSPITAL, THE PT WAS REPORTEDLY IN STABLE CONDITION. THE PATIENT'S DEVICE REMAINED IMPLANTED AT THE TIME OF THE INCIDENT. THIS IS THE FINAL REPORT.

Description of Event or Problem · 1

DURING THE REVIEW OF THE PATIENT'S MEDICAL RECORDS PROVIDED BY LEGAL, THE COMPANY WAS INFORMED THAT THE PT EXPERIENCED A CSF LEAK DURING THE IMPLANT SURGERY. TISSEEL AND FASCIA WERE PACKED AROUND THE ARRAY AND THE MASTOID CAVITY WAS FILLED WITH SEPRAGEL. ACCORDING TO THE DOCTOR, THE CSF LEAK WAS SOMEWHAT ANTICIPATED BECAUSE OF THE PATIENT'S EAR ANATOMY. THE PT REMAINED IN THE HOSPITAL FOR TWO EXTRA DAYS DUE TO THE CSF COMPLICATION. THE PT WAS PRESCRIBED KEFLEX AND COLACE AND PUT ON CSF PRECAUTIONS OF NO STRENUOUS ACTIVITY UPON DISCHARGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HIRES 90K	COCHLEAR IMPLANT	MCM	ADVANCED BIONICS CORPORATION	CI-1400-01	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 MO		Hospitalization\| R