MAUDE Adverse Event Report: MEDTRONIC, INC. AZURE XT DR MRI SURESCAN; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number W1DR01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Inflammation (1932)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: allergic reaction to an antibiotic-impregnated envelope masquerading as pocket infection.Heart rhythm case reports.2023; 9:794¿796.Doi: 10.1016/j.Hrcr.2023.08.006 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding an allergic reaction to an antibacterial absorbable envelope.The authors described a patient who underwent a generator replacement, and the new device was implanted with an antibacterial absorbable envelope.Within a week, the wound was partially dehisced at the edges with serosanguineous incisional drainage that persisted despite application of wound closure strips and a pressure dressing.A pocket infection was suspected, so they performed a system extraction which included debridement and closed the pocket.The pocket contained serosanguineous fluid with no purulence.Wound and blood cultures were negative while the patient was on antibiotics.Three days later, the patient was reimplanted and again an antibacterial absorbable envelope was used.The patient was discharged on antibiotics for two weeks.Within a week, the patient again had wound dehiscence and serosanguineous incisional drainage.The patient was again admitted and underwent device removal.Pathologic specimen from the pocket demonstrated foreign body reaction with lymphoplasmacytic and focal neutrophilic inflammation most consistent with allergic reaction.Three days later, the patient underwent implantation in a different location without the use of an antibacterial absorbable envelope.The patient was discharged without antibiotics and without evidence of infection or allergy at the new surgical site.No additional adverse patient effects were reported.

• Brand Name: AZURE XT DR MRI SURESCAN
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19043231
• MDR Text Key: 339433391
• Report Number: 2182208-2024-01474
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: W1DR01
• Device Catalogue Number: W1DR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/04/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN LEADS
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male