MAUDE Adverse Event Report: SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Itching Sensation (1943); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Burning Sensation (2146); Insufficient Information (4580)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial#: (b)(4), product type: lead.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

A consumer implanted for non-malignant pain reported during surgery on (b)(6) 2016 the surgeon accidentally hit some nerve bundles, and as a result they now had incontinence and neuropathy in their left foot (itching and burning).The healthcare provider (hcp) told them these issues would likely go away but they hadn't.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: on (b)(6) 2015 explanted: on (b)(6) 2016 product type lead product id 977a260 lot# serial# (b)(6) implanted: explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: on (b)(6) 2015 explanted: on (b)(6) 2016 product type lead product id 977a260 lot# serial# (b)(6) implanted: 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.

Event Description

Additional information was received on october 11, 2021.The patient reported that after the 2016 implant procedure, the patient was left with "deficits".They connected the deficits with the laminectomy that was performed to insert the surgical leads in 2016.They also mentioned that nobody had prepared them for the level of pain they experienced during that surgery.

Event Description

Additional information was received from the healthcare provider (hcp).Caller called in to reach local rep.Caller states they want info regarding complication that occurred during procedure to place the latest ins and lead.Caller did not know what the complication was.

Manufacturer Narrative

Continuation of d10: product id 977a260.Serial# (b)(6) implanted: (b)(6) 2015, explanted: (b)(6) 2016.Product type lead.Product id 977a260, serial# (b)(6).Product type lead.Product id 977a260, serial# (b)(6) implanted: (b)(6) 2015, explanted: (b)(6) 2016.Product type lead.Product id 977a260, serial# (b)(6).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.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: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• MDR Report Key: 5841369
• MDR Text Key: 50976146
• Report Number: 3004209178-2016-15403
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/01/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: 07/13/2016; 10/11/2021; 10/28/2021
• Supplement Dates FDA Received: 09/24/2017; 10/18/2021; 11/01/2021
• Date Device Manufactured: 10/29/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR