MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION XTREL

Model Number 3470

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3487a lot# l17626 serial# implanted: (b)(6) 1990 explanted: (b)(6) 2021 product type lead product id 7495 lot# serial# (b)(4).Implanted: (b)(6) 1990 explanted: (b)(6) 2021 product type extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had increased pain at ins site pocket. when the hcp opened the pocket where the ins was placed there was a white substance inside the pocket and had ingrown a flaky white hard tissue.The tissue was difficulty cutting through and trying to remove the extension wires.There were no contributing factors noted.The entire system was explanted.The issue was resolved.

Manufacturer Narrative

Product id 3487a lot# l17626 implanted: (b)(6)1990 explanted: (b)(6)2021 product type lead product id 7495 lot# serial# (b)(6) implanted: 1990-01-22 explanted: 2021-06-21 product type extension 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

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

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

The patient reported additional information that the implanted neurostimulator (ins) was explanted on (b)(6)2021 because the ins had cracked open and was leaking into their system.The explanting physician was not able to remove all of the material that had gotten into the fatty tissue around the ins.The patient stated they did not have high blood pressure until they started having problems with the ins, which was around (b)(6)2021, but the patient also reported that they had problems on and off for the last two years around the ins site in their back on the right side.The patient also reported they started to get physically ill and was nauseous, which began about 6 months prior to the explant surgery.The doctor thought that whatever was leaking out of the ins and found in the fatty tissue could be a contributing factor for the high blood pressure.The hcp had requested information about what happened with the ins after the rep took it away because it looked like battery acid to the physician.The patient also noted that they had several ct scans because physicians thought perhaps the patient had kidney stones or other kidney problems.The pains in their back would subside and then come back.The patient was redirected to their doctor and the reps were notified that the patient and the physician were still waiting to find out what happened with the ins since their future treatment will be dependent on that.

Manufacturer Narrative

Product analysis #704460371:analysis information -- 2021-11-12 13:06:29 cst pli# 30 product id# 3470 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and functional output testing.Analysis determined that there was a leak in the adhesive bead at the epoxy-connector block junction of the stim receiver.Continuation of d10: product id 3487a lot# l17626 implanted: (b)(6) 1990 explanted: 2021-06-21 product type lead product id 7495 lot# serial# (b)(6) implanted: (b)(6) 1990 explanted: 2021-06-21 product type extension h3: analysis of the 3470 receiver (s/n (b)(6)) determined that there was a leak in the adhesive bead at the epoxy-connector block junction of the stim receiver.The returned devices were received with a foreign material (white flaky) observed to be on the receiver and extension.A sample of the foreign material was sent to chemical technologies for analysis.The foreign material was analyzed by chem tech and determined that calcium phosphate appears to be a major component of the sample.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: XTREL
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12066717
• MDR Text Key: 258328393
• Report Number: 2182207-2021-01122
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904409A
• 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,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3470
• Device Catalogue Number: 3470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male