MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 97714

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Nerve Damage (1979); Pain (1994); Cognitive Changes (2551); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

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 patient reported he needs an mri because ever since the implantable neurostimulator (ins) was implanted he has had abdominal pain.The patient states after implant surgery he was in the hospital for 9 days.The patient further reported that if they can't figure out how to resolve, then he wants the ins removed.The patient stated he needs to have an mri of the abdomen and according to his device manufacturer registration and his patient programmer he is mri full body eligible.The patient stated the problem is that the mri facility has the paperwork from the healthcare provider (hcp) who performed the implant and this paperwork shows that the pt has a non surescan lead and the mri facility won't do the mri because of the discrepancy.The hcp who performed the implant could not be contacted for verification.The patient wanted to know how he can find out what lead is in the body.It was reviewed that the patient programmer mri mode displaying mri eligibility was not reading what is in the body, but rather information that it was programmed to show.The patient was informed that they could have an x-ray to determine if they are surescan leads or not.The patient was redirected to their healthcare provider.The indication for implant was spinal pain.

Manufacturer Narrative

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

Manufacturer Narrative

Other applicable components are: product id 977c165 serial# (b)(4) implanted: (b)(6) 2016 product type lead.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 from the patient on 2019-feb-11.It was reported that the patient had abdominal pain since the implantable neurostimulator (ins) was implanted.The patient also reported that their healthcare professional (hcp) put the paddle leads on the patient¿s nerve instead of away from the nerve.The patient wanted the device removed.There were no further complications reported or anticipated.

Event Description

Additional information was received on 2021-sep-27.The patient reported that in 2016, the device caused them pain and caused spinal cord damage.The patient stated the surgeon did not want to take the device out as it may cause more damage.The patient inquired about financial compensation.They were redirected to their doctor and an email was sent to patient relations.

Manufacturer Narrative

Continuation of d10: product id: 977c165, serial#: (b)(6),implanted: (b)(6) 2016, 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.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6508466
• MDR Text Key: 73326031
• Report Number: 3004209178-2017-08731
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,literature
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR