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

Model Number	2100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445 1925
• MDR Report Key: 7134425
• Report Number: 3007972010-2017-00003
• Device Sequence Number: 1310513
• Product Code: DSR
• UDI-Device Identifier: 00859144004210
• UDI-Public: (01)00859144004210(17)171218
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: H130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR