MAUDE Adverse Event Report: CVRX, INC. NEO LEGACY; IMPLANTABLE PULSE GENERATOR

Model Number 2100

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

Sterilization records of the ipg sterilization lot were reviewed and showed no issues with the sterilization process or acceptance.(b)(4).Based on these data, the infection rate is below that which might be expected.

Event Description

Patient had ipg replaced on (b)(6) 2015.Patient was seen by his primary care physician on (b)(6) 2015 and the pocket was infected.Reported that the incision had opened up slightly and had pus coming from around the wound.

• Brand Name: NEO LEGACY
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• Manufacturer Contact: al crouse ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445 ; 7634167457
• MDR Report Key: 5292774
• MDR Text Key: 33401153
• Report Number: 3007972010-2015-00001
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 0085914404210
• UDI-Public: (01)0085914404210(17)170127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/27/2017
• Device Model Number: 2100
• Device Catalogue Number: 100053-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2015
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 100