MAUDE Adverse Event Report: ABBOTT PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3211-36
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a routine device replacement procedure, the right atrial lead was unable to be removed from the device header.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
Additional information: the reported event of difficulty disconnecting the atrial lead could not be verified.The device was analyzed in the lab; the is-1 (tip) set screw and septum were missing when the device was received.Septum debris was noted inside the is-1 (ring) set screw, which was consistent with explant procedure.The is-1 (ring) set screw was cleaned up and a test set screw was used for the is-1 (tip).The screws operated normally in affixing a lead to the device.The atrial lead impedance and sensing were tested afterwards, and no anomalies were detected.

• Brand Name: PROMOTE PLUS CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9129911
• Report Number: 2938836-2019-14017
• Device Sequence Number: 2478062
• Product Code: NIK
• UDI-Device Identifier: 05414734503693
• UDI-Public: 05414734503693
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 06/30/2014
• Device Model Number: CD3211-36
• Device Catalogue Number: CD3211-36
• Device Lot Number: 3892273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1