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

Model Number	2100
Health Effect - Clinical Code	Twiddlers Syndrome (2114)
Date of Event	06/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A pocket revision procedure was scheduled on monday, (b)(6) 2016 at 8am with dr.(b)(6) at the (b)(6) as the patient lives in (b)(6).The patient had a device replacement last (b)(6) in (b)(6) and it appears from x-ray that the device has moved in the pocket and the lead has become twisted since that time (possible twiddler's syndrome).The patient was unable to come in for an interrogation to assess the condition of the leads, so it was not clear if a repair would be needed in addition to the pocket revision.(b)(4) was present for the case.He brought lead repair kits a replacement ipg in case it was damaged, but they were not necessary.The procedure was completed by a fellow, not dr.(b)(6).Dr.(b)(6) attended though.The lead impedance was normal throughout.The leads were "balled" together, as seen on the x-ray, and scarred in.No attempt was made to dissect them out.A lead repair was not required.The leads were not removed from the ipg during the procedure.(b)(4) was not able to determine the status of the ipg before it was removed from the pocket, so was not sure if it was actually sutured in.He did not see any sutures cut from the ipg or removed from the pocket though.The surgeon used ethibond 0 to suture the device into the pocket, both ipg suture holes were used, the sutures were definitely placed into the fascia of the muscle.The device had to be rotated 180 degrees to fit back into the medial area of the pocket, so the leads are now facing lateral (towards the shoulder).(b)(4) agreed that this was appropriate for this situation.
Event or Problem Description
Patient complained of pain and bruising on (b)(6) 2016 due to device moving out of the pocket.The last ipg replacement surgery took place on (b)(6) 2015 at (b)(6).Photos and x-rays sent on (b)(6) 2016 showed that the ipg had shifted in the pocket and the leds were intertwined but did not appear to be damaged.
Additional Manufacturer Narrative
A pocket revision procedure was scheduled on monday, (b)(6) 2016 at 8 am with dr.(b)(6) at (b)(6) as the patient lives in (b)(6).The patient had a device replacement last (b)(6) in (b)(6) and it appears from x-ray that the device has moved in the pocket and the lead has become twisted since that time (possible twiddler's syndrome).The patient was unable to come in for an interrogation to assess the condition of the leads so it was not clear if a repair would be needed in addition to the pocket revision.(b)(6) was present for the case.He brought lead repair kits a replacement ipg in case it was damaged, but they were not necessary.The procedure was completed by a fellow, not dr.(b)(6).Dr.(b)(6) attended though.The lead impedance was normal throughout.The leads were "balled" together, as seen on the x-ray, and scarred in.No attempt was made to dissect them out.A lead repair was not required.The leads were not removed from the ipg during the procedure.(b)(6) was not able to determine the status of the ipg before it was removed from the pocket, so was not sure if it was actually sutured in.He did not see any sutures cut from the ipg or removed from the pocket though.The surgeon used ethibond 0 to suture the device into the pocket, both ipg suture holes were used, the sutures were definitely placed into the fascia of the muscle.The device had to be rotated 180 degrees to fit back into the medial area of the pocket, so the leads are now facing lateral (towards the shoulder).(b)(6) agreed that this was appropriate for this situation.Follow-up report is submitted to correct initial report that stated this was 5 day reportable.This was incorrect.This was a 30 reportable event.
Event or Problem Description
Patient complained of pain and bruising on (b)(6) 2016 due to device moving out of the pocket.The last ipg replacement surgery took place on (b)(6) 2015 at (b)(6).Photos and x-rays sent on (b)(6) 2016 showed that the ipg had shifted in the pocket and the leds were intertwined but did not appear to be damaged.

• Brand Name: NEO LEGACY
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445
• MDR Report Key: 5723532
• Report Number: 3007972010-2016-00001
• Device Sequence Number: 18875481
• Product Code: DSR
• UDI-Device Identifier: 00859144004210
• UDI-Public: (01)00859144004210(17)170825
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: H130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2016

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
• Operator of Device: Physician
• Device Expiration Date: 08/25/2017
• Device Model Number: 2100
• Device Catalogue Number: 100053-301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2016
• Supplement Report FDA Received Date: 06/30/2016
• 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: Hospitalization; Required Intervention