MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number B35200

Device Problems Connection Problem (2900); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Dysphasia (2195)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: b3400060, serial# (b)(4), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type :extension; product id b3301542m, serial# (b)(4), implanted: (b)(6) 2022, explanted: product type: lead; other relevant device(s) are: product id: b3400060, serial/lot #: (b)(4), ubd: 20-apr-2023, udi#: (b)(4) ; product id: b3301542m, serial/lot #: (b)(4), ubd: 22-dec-2023, and udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during stage ii, system would not pass connectivity test.When the manufacturer representative ran an impedance test, everything came back normal except for contact 3.The extension seemed to give more resistance than usual and would not seat all the way down. new extension was opened and all issues resolved.  cause was unknown at time of report. after patient was discharged, patient complained of difficulty verbalizing thoughts and felt like his speech had been affected. patient did not show any signs of deficit during case. ct was ordered on mar-08 and manufacturer representatives were notified on mar-09 at his stage ii.His ct showed a small bleed approximately 10mm beyond target possible cause that was identified was that depth was set incorrectly on mi2000.This is not resolved at time of report.

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.

Event Description

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported no actions/interventions were taken related to the cranial bleed beyond getting proper imaging to monitor.The stimulation to the existing battery was turned on/off to test effect on speech but didn¿t seem to make a difference related to the patient¿s speech.The plan was to monitor the bleed and symptoms to see if it resolved on its¿ own.

Event Description

Additional information was received from the manufacturer¿s representative (rep) stating no actions were taken to resolve the crania l bleed due to the size.Hcp thinks patient should regain lost abilities over time.Rep will contact hcp for further information.The issue has not resolved and status is unchanged.Rep will be able to update after patient's surgical follow up appointment next week.

Manufacturer Narrative

Continuation of d10: product id b3400060 lot# serial# (b)(6), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type extension p roduct id b3301542m lot# serial# (b)(6), implanted: (b)(6)2022, explanted: product type lead.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.

Manufacturer Narrative

Continuation of d10: product id b3400060, serial# (b)(6), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type extension p roduct id b3301542m, serial# (b)(6), implanted: (b)(6) 2022, explanted: product type lead h3: analysis of the extension va2djg4 found no anomalies.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: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 13736134
• MDR Text Key: 287029640
• Report Number: 2182207-2022-00405
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000519216
• UDI-Public: 00763000519216
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male