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

Model Number B35200

Device Problems Degraded (1153); High impedance (1291); Application Program Problem (2880); Insufficient Information (3190)

Patient Problems Numbness (2415); Shaking/Tremors (2515); Paresthesia (4421)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id 3387s-40, serial# (b)(4), product type: lead.Product id 3387s-40, serial# (b)(4), product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4).Product id: 3387s-40, serial/lot #: (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 yesterday when the patient was taking a shower, the patient felt tingling, numbing and his tremors are now back.Patient is also getting error code 1703 oor message on the controller.Manufacturer representative (rep) will meet the patient at the healthcare provider (hcp) office.Additional information received from the manufacturer¿s representative (rep) reported the cause of the error message wasn't known, but the patient had follow-up appointments this week with their surgery team to interrogate the battery and discuss a potential revision as the patient was still experiencing symptoms.Additional information received from the manufacturer¿s representative (rep) reported the patient came in for battery interrogation and was found to have high impedances on contact 8.The surgery team decided to do surgery to find out more.The physician opened the pocket and found contact 8 was completely corroded and had black residue all around it.The decision was made to replace the battery again, and clean off the contact, then try to program around contact 8 utilizing different contacts.The surgery went well, and the patient no longer felt the tingling/zapping feeling upon interrogation of the battery and regular therapy.

Manufacturer Narrative

Analysis of the ins (s/n (b)(6)) found no significant anomaly.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 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: 16767650
• MDR Text Key: 313559023
• Report Number: 3004209178-2023-05233
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000642174
• UDI-Public: 00763000642174
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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 Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male