MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CURRENT ACCEL DR, 36J; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2215-36
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that lead noise issue and it was suspected that the lead noise was due to set screw being damaged or loose prior to the procedure.Physician went to unscrew the atrial lead and the set screw popped out.Device was explanted and a new device was implanted because a new battery was needed as well.Atrial lead was chronic and remained in place and implanted with the new implanted device.There was no noise with the new device.Patient was stable during the procedure.No further information available.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• Brand Name: CURRENT ACCEL DR, 36J
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7838544
• Report Number: 2938836-2018-10311
• Device Sequence Number: 11371173
• Product Code: NVZ
• UDI-Device Identifier: 05414734502641
• UDI-Public: 05414734502641
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2019

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: 08/31/2011
• Device Model Number: CD2215-36
• Device Lot Number: 3256540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 04/10/2019; 08/15/2019
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 04/10/2019; 08/16/2019
• 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: Required Intervention
• Patient Age: 71 YR