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

Model Number 2100

Device Problem Fracture (1260)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/30/2017

Event Type  Injury  

Event Description

A double lead repair was done at (b)(6) on (b)(6) 2017 during a normal ipg replacement.Ipg (b)(4) was replaced with (b)(4).The right lead was severed, and the terminal pin was missing, so that lead was fixed first.Dr.(b)(6) successfully repaired the lead resulting in an impedance of 349.Neo lead repair kit (b)(4) was used to repair the right lead.The outer coil on the left lead was stretched out between the terminal pin and tubing around the lead serial number label, but it still showed good connectivity with an impedance of 377.To reinforce this section of the lead, dr.(b)(6) put a tube around this portion and filled it with silicone adhesive.The final impedance for the left lead was 376.The patient had not been experiencing any symptoms leading up to the ipg replacement and lead repairs.

Manufacturer Narrative

Evaluation of the returned device included the ipg (serial number (b)(4)) and part of the right lead (serial number (b)(4)).There were no anomalies found with the ipg, and it was functioning as intended when analyzed.The portion of the lead returned included a section with the serial number and a stretched out section of the coil.The lead was returned in two sections.The area of the lead that was fractured due to the design issue was not returned.

Event Description

A double lead repair was done at (b)(6) on (b)(6) 2017 during a normal ipg replacement.Ipg (b)(4) was replaced with (b)(4).The right lead was severed, and the terminal pin was missing so that lead was fixed first.Dr.(b)(6) successfully repaired the lead resulting in an impedance of 349.Neo lead repair kit (b)(4) was used to repair the right lead.The outer coil on the left lead was stretched out between the terminal pin and tubing around the lead serial number label, but it still showed good connectivity with an impedance of 377.To reinforce this section of the lead, dr.(b)(6) put a tube around this portion and filled it with silicone adhesive.The final impedance for the left lead was 376.The patient had not been experiencing any symptoms leading up to the ipg replacement and lead repairs.

• Brand Name: NEO LEGACY
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445 1925
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445 1925
• Manufacturer Contact: sarah hicks ; 9201 west broadway avenue; suite 650; minneapolis, MN 55445-1925 ; 7634162844
• MDR Report Key: 7134425
• MDR Text Key: 95371157
• Report Number: 3007972010-2017-00003
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004210
• UDI-Public: (01)00859144004210(17)171218
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/18/2017
• Device Model Number: 2100
• Device Catalogue Number: 100053-301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• 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): Required Intervention
• Patient Age: 60 YR