NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

MDR report key: 1832487 · Received September 13, 2010

Report

Report Number: 6000034-2010-00601
Event Type: Injury
Date Received: September 13, 2010
Date of Event: July 18, 2010
Report Date: May 27, 2011
Manufacturer: COCHLEAR LTD.
Product Code: MCM
PMA / PMN Number: 970051
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: AUDIOLOGIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

CORRECTION: THE CORRECT DATE OF SURGERY IS (B)(6), 2010, NOT (B)(6), 2010 AS PREVIOUSLY REPORTED. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4)

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFO THAT MICRO-DISLODGEMENT OF THIS LEAD WAS SUSPECTED. A LEAD REVISION WAS PERFORMED AND DURING THE REPOSITIONING OF THE LEAD, HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OF GREATER THAN 2400 OHMS WERE OBSERVED. THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2010, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

Description of Event or Problem · 1

IT WAS REPORTED IN AN ARTICLE IN NEUROSURGERY THAT A PATIENT SUFFERED AN ASYMPTOMATIC BRAIN STEM PERFORATING ARTERY OCCLUSION. NO OTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM	MCM, PRODUCT CODE: MCM	MCM	COCHLEAR LTD.	CI24RE (CA)	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention