MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Staphylococcus Aureus (2058); No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had undergone a surgical procedure for lead revision.The physician suspected that the device pocket was infected due to the excessive fluid that was drained.Cultures were taken and the results were negative for signs of infection.The patient was diagnosed with diabetes and obesity, which was noted to be comorbidities.The pacemaker explanted and is no longer in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had undergone a surgical procedure for lead revision.The physician suspected that the device pocket was infected due to the excessive fluid that was drained.Cultures were taken and the results were negative for signs of infection.The patient was diagnosed with diabetes and obesity, which was noted to be comorbidities.The pacemaker explanted and is no longer in service.No additional adverse patient effects were reported.Additional information indicates that the pocket was cleaned out and irrigated with antibiotics solution.The patient was treated with intravenous antibiotics for empiric methicillin resistant staphylococcus aureus (mrsa).There were no additional adverse patient effects reported.The crt-p was explanted.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8821651
• MDR Text Key: 152041643
• Report Number: 2124215-2019-14582
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 739348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR