MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M

Model Number B35200

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 3708640, serial#: (b)(4), implanted: (b)(6) 2016, product type: extension.Product id: 3708640, serial#: (b)(4), implanted: (b)(6) 2016.Product type: extension.Other relevant device(s) are: product id: 3708640, serial/lot #: (b)(4), ubd: 06-jul-2020, udi#: (b)(4).Product id: 3708640, serial/lot #: (b)(4), ubd: 06-jul-2020, udi#: (b)(4).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.

Event Description

It was reported that patient (pt) came in for programming with healthcare provider (hcp).Pt needed to be optimized as pt was experi encing symptoms after upgrade to percept pc.Hcp turned stim up and pt was much better.Hcp said he was not sure if manufacturer representative (rep) didn't turn still completely to equivalent of cc needed. while there pt complained of pain in left neck where extensions were.Pain worsens when he turns his head left/right.Pt also said they felt ins moving which also irritated/hurt.Contributing factors may include pt had ins battery change (due to normal eri) in his home state on (b)(6) 2022.He said he told surgeon that it felt tight previously and if he could "loosen/slack" to see if that would help.But pt complains it feels worse than before.Troubleshooting included hcp looking an incisions and extensions.Hcp sees a bit of extension bowing.Manufacturer representative is not sure if it's left/right or both.Hcp did not see any sign of infection.All impedances were within normal limits.Pt is getting symptom control from programming today.Hcp told pt to monitor.Rep has reached out to rep in patient's home state via email to get more details but has not heard back yet.Hcp said it's only been a week since he had the surgery, so it may get better with a bit more time, but pt should keep them posted.The issue has been resolved.

Manufacturer Narrative

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
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15772027
• MDR Text Key: 307980747
• Report Number: 2182207-2022-02099
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Date Device Manufactured: 07/21/2022
• 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 Sex: Male