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

Model Number	CD3215-36Q
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	Dizziness (2194); Complete Heart Block (2627)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that when the patient presented in the emergency room with lightheadedness and pre-syncope, it was observed that the patient's device was past elective replacement indicator (eri) and had gone into backup mode.The patient was in complete heart block with a ventricular rate of 23 beats per minute and needed external pacing.The physician replaced the device and the patient was stable following.
Additional Manufacturer Narrative
Interrogation of the device revealed the device was at below end of life (eol) when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The device functionality was bench tested and no anomaly was detected.Based on this information, there was no evidence of device malfunction.

• Brand Name: PROMOTE ACCEL 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: 9332014
• Report Number: 2938836-2019-15868
• Device Sequence Number: 19486882
• Product Code: NIK
• UDI-Device Identifier: 05414734503099
• UDI-Public: 05414734503099
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 08/31/2011
• Device Model Number: CD3215-36Q
• Device Catalogue Number: CD3215-36Q
• Device Lot Number: 3095438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 67