MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PERCEPT

Model Number B35200

Device Problems High impedance (1291); Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the manufacturer¿s representative (rep) who reported there was an out of box failure.The rep was in a procedure changing out a primary cell battery to a percept device.Coming into the procedure, all impedances were in normal range.Once the extensions were connected to the implantable neurostimulator (ins), all pairs were showing red except for 0/8 pair which was in the normal range.They tried wiping down the extensions and reinserting them into the ins but impedances were still high.They went back to the previous battery and impedances were still all in normal range.They then connected the extensions to the percept ins and got the same results as before with all pairs being red/out of range and 0/8 being normal.The rep didn't have the exact numbers at the time of the call.The healthcare provider (hcp) stated there was no difficulty putting the leads into the header block, and programming of the electrodes was correct.It was reviewed that the impedance issue seemed related to the ins so they could con sider changing out the ins if impedances weren't resolving.

Manufacturer Narrative

Additional review indicates this information was already reported in manufacturer¿s report #3004209178-2021-00837.Any additional information regarding the event will be submitted as a supplemental submission to that report.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPT
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11178383
• MDR Text Key: 228399806
• Report Number: 2182207-2021-00079
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1