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	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinic follow up, it was noted that the device had an alert for elective replacement indicator (eri) due to suspected premature battery depletion.The device was explanted and replaced to resolve the event and the patient was stable with no adverse consequences reported.
Additional Manufacturer Narrative
Additional information: the reported field event of a premature depletion was not confirmed.Longevity analysis found the battery depletion to be normal.Sensing, pacing, pacing lead impedance, high voltage (hv) lead impedance, hv charging, hv delivery and hv shock impedance were tested with no anomalies noted.

• 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: 8040035
• Report Number: 2938836-2018-11925
• Device Sequence Number: 11088275
• Product Code: NVZ
• UDI-Device Identifier: 05414734503075
• UDI-Public: 05414734503075
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: CD2215-36Q
• Device Lot Number: 3070058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 08/25/2019
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention