FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1760323
·
Received July 16, 2010
Report
- Report Number
- 6000034-2010-00458
- Event Type
- Malfunction
- Date Received
- July 16, 2010
- Date of Event
- June 11, 2010
- Report Date
- September 27, 2010
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6), 2010 DUE TO A PERFORMANCE DECREMENT. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A BATTERY STATUS OF END OF LIFE (EOL). CURRENTLY, THE CHARGE TIME WAS 34.3 SECONDS. AT THE PRIOR FOLLOW-UP VISIT SIX MONTHS AGO, THE CHARGE TIME WAS 15.6 SECONDS WITH A BATTERY STATUS OF MIDDLE OF LIFE 2 (MOL2). THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24R (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Required Intervention |