MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 7304

Model Number 7304-20

Device Problem High impedance (1291)

Patient Problem Fatigue (1849)

Event Date 11/18/2020

Event Type  malfunction  

Event Description

Patient presented with high impedance.The device was disabled and x-rays were performed.It was noted that the patient typically has muscle spasms with stimulation but this became less frequent 20 days prior, and within 2 days it completely disappeared.The patient also noted that his body feels heavier than before but he did not notice any other changes.The patient noted he has had no physical trauma recently.The device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.X-rays were reviewed.The feedthrough wires appear intact.Due to the angle and quality of the image, it was unable to be assessed if the lead pin is fully inserted into the connector block.No sharp angles were observed in the lead.The lead was assessed for fractures and no gross fractures or discontinuities were noted.The lead wires appear intact at the connector pin.The lead is not routed behind the generator.Based on the x-rays received, the cause of the high impedance cannot be confirmed.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Manufacturer Narrative

H6.Corrected data, initial report: inadvertently did not use method code 3331.

Event Description

Per the physician, the patients report of body feeling heavier was not an adverse event but was a normal fluctuation in body sensation.The patient was noted to be doing well and having no symptoms following the device being turned off.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 7304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10973022
• MDR Text Key: 220700207
• Report Number: 1644487-2020-01650
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2022
• Device Model Number: 7304-20
• Device Lot Number: 204573
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR