MAUDE Adverse Event Report: ABBOTT CRM; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5480
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.  .
Event or Problem Description
During implant, inability to loosen set screw was noted on the device.The device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
Analysis found in both cases of the atrial and ventricular setscrews, the wrenches were not being fully inserted into the setscrew insets.With partial insertion of the wrench, it is not engaging enough of the inset to untighten the setscrew and it will lose its grip on the inset and begin to turn around in the inset and strip it.The insets of both setscrews were partially stripped.Nothing was revealed in the setscrew insets to prevent the user from making adequate wrench insertions.Testing revealed the setscrews could be tightened and loosened normally.Battery analysis was at normal eri.

• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT CRM; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8735097
• Report Number: 2017865-2019-10087
• Device Sequence Number: 13929436
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

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: 01/31/2012
• Device Model Number: 5480
• Device Lot Number: 3173709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/09/2019; 09/18/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/21/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 85