MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT

Model Number B35200

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Date 08/17/2021

Event Type  malfunction  

Event Description

It was reported that when the patient would rub where the lead meets extension right above their ear they would feel first pain with a jolt "charge" sensation that would turn into a numbing sensation down their neck that felt similar to the sensation one gets when they hit their funny bone.The circumstances that led to the reported issue were asked but unknown.The patient went to their managing hcp 3 weeks to a month ago and the hcp referred the patient to see a surgeon.The issue was not resolved.The patient will make appointment with surgeon.

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.Patient states that the cause of the issue was not determined.An x-ray of the side of their skull and cable was ordered.The x-ray did not show any break in wire.Patient reports the issue has not been resolved and it is still a very defensive issue.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead lot# serial# unknown.Product type lead product id neu_unknown ext lot#/serial# unknown.Product type extension product id neu_unknown_lead lot#/serial# unknown, product type lead a4: additional information, patient weight b5: additional information received.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12884133
• MDR Text Key: 281341733
• Report Number: 3004209178-2021-17691
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000420987
• UDI-Public: 00763000420987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/23/2021
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 68 KG