MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CD2215-36Q CURRENT ACCEL DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2215-36Q
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During follow-up, automatic mode switching (ams) due to oversensing was noted.Reprograming was performed to resolve the issue.The patient was in stable condition.Manufacturer report number: 2017865-2018-14758.

• Brand Name: CD2215-36Q CURRENT ACCEL DR ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7938029
• Report Number: 2938836-2018-11078
• Device Sequence Number: 19194757
• Product Code: NVZ
• UDI-Device Identifier: 05414734503075
• UDI-Public: 05414734503075
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: CD2215-36Q
• Device Lot Number: 3305492
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1944/52, (B)(4)
• Patient Age: 70 YR