MAUDE Adverse Event Report: ABBOTT 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5356
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During normal device replacement procedure, the lead was unable to be removed from the device header.The event was resolved by explanting and replacing the device after cutting the lead during the normal device replacement procedure.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of could not remove the ventricle lead was confirmed.The device was at elective replacement indicator (eri) upon receipt.Analysis revealed that blood in the front entry seals of the v-connector port was holding the lead in place preventing it from removing.The front seals were normal.Excess blood was most likely not removed from the lead by the physician during implant.The blood that was holding the lead was removed then the lead could be removed from the connector normally.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15026788
• Report Number: 2017865-2022-15226
• Device Sequence Number: 14598092
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 08/31/2010
• Device Model Number: 5356
• Device Catalogue Number: 5356
• Device Lot Number: 2919239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown