MAUDE Adverse Event Report: ABBOTT VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5256
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2020
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 device exchange procedure to address normal battery depletion, the ventricular lead could not be removed from the header of the device after repeated attempts to loosen the set screws.The lead was cut and capped so that the device could be explanted, and a new device and lead were implanted.The patient was in stable condition.
Additional Manufacturer Narrative
The reported complaint of could not untighten the v-setscrew to remove the lead was confirmed.Analysis found that calcified blood was filling the v-setscrew inset.The calcified blood was preventing the wrench from engaging the v-setscrew inset to untighten the setscrew.With the blood removed from the setscrew inset a wrench could be fully inserted into and engage the setscrew inset and untighten the setscrew and remove the lead.The blood most likely came through a hole punched through the septum by the torque wrench in the field.Electrical testing revealed the battery voltage is above eri.

• Brand Name: VERITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10512089
• Report Number: 2017865-2020-13301
• Device Sequence Number: 2445336
• Product Code: DXY
• UDI-Device Identifier: 05414734006811
• UDI-Public: 05414734006811
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 05/31/2009
• Device Model Number: 5256
• Device Catalogue Number: 5256
• Device Lot Number: 2917592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1