MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT ACCEL VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1215-36Q
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that when the patient presented via remote transmission in march, her device had an estimated longevity of 1.5 years.The patient's device reached elective replacement indicator (eri) in october.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
New information received notes that the device was explanted and replaced.The patient was stable before, during and after the procedure.
Additional Manufacturer Narrative
The reported event of diagnostic anomaly was most likely due to programmer software issue.The device interrogation revealed the device was at elective replacement indicator when received.Longevity estimation and battery voltage was found to be within expected limits.The device was tested on the bench.Analysis was normal.No anomalies were found.

• Brand Name: CURRENT ACCEL VR ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9338735
• Report Number: 2938836-2019-16142
• Device Sequence Number: 13557917
• Product Code: NVZ
• UDI-Device Identifier: 05414734503044
• UDI-Public: 05414734503044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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: 11/30/2011
• Device Model Number: CD1215-36Q
• Device Catalogue Number: CD1215-36Q
• Device Lot Number: 3218109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/29/2020; 04/01/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/14/2020; 04/14/2020
• 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: Required Intervention