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

Model Number 97714

Device Problems Break (1069); Electromagnetic Interference (1194); High impedance (1291); Battery Problem (2885)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins).It was reported that during reprogramming high impedances were noted on electrodes 1,3, 8,9,10 and 11. impedances were checked and patient was asked if he had any recent falls, changes in stim.Patient reported increased neck pain that started recently but is not sure if it is related to the device.He showed the rep pictures that had been taken of the device a while ago but did not specify if they had been taken recently, or by which provider since he is a new patient.The rep programmed around high impedances.Patient was told to get a ct scan by provider.Will be seen again on january 13th 2021 to discuss findings.The issue is not yet resolved.

Manufacturer Narrative

Continuation of d10: product id: 3776-75, serial# (b)(6), implanted: (b)(6) 2009; product type: lead.Product id: 3776-75, serial# (b)(6), implanted: (b)(6) 2009, 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 from the rep.The rep reported that the patient had seen power on reset (por) message on his recharger.The patient's device was too low for the rep to interrogate with her tablet.The patient was currently charging.The rep reported that the patient did not perform physician recharge mode.The patient was able to charge normally.The rep reported that the patient had a ct scan about 2 weeks ago and the por started then.The patient had turned his stimulation off prior to ct scan.It was suggested continue charging ins until pass 25% full than interrogate ins for further assessment on por message.The rep later reported that the patient charged and they interrogated the battery.The clinician programmer displayed a message that the ins had been reset.The rep was able to turn stimulation on.The rep also reported that the patient was to have a lead revision because of the high impedances.The following values were reported from the impedance test: ref 0 1 >10000ohms 2 9779 3 >10000ohms 4 6197ohms 5 5211ohms 6 5173ohms 7 5085ohms 8 >10000ohms 9 >10000ohms 10 >10000ohms 11 >10000ohms 12 5235ohms 13 5013ohms 14 5289ohms 15 5275ohms.

Manufacturer Narrative

Continuation of d10: product id: 3776-75, serial # (b)(6), implanted: (b)(6) 2009, product type: lead.Product id: 3776-75, serial # (b)(6), implanted: (b)(6) 2009, 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.

Event Description

The rep reported that the cause of the por message and high impedances wasn't determined.The rep programmed around the impedances.The rep reported that the patient would go for a lead revision and the date was unknown.The patient was referred to another doctor.

Manufacturer Narrative

Continuation of d10: product id 3776-75, serial# (b)(6), implanted: (b)(6) 2009, explanted: (b)(6) 2022, product type lead product id 3776-75, serial# (b)(6), implanted: (b)(6) 2009, explanted: (b)(6) 2022, 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 reported that the patient had a full system replacement.It was also reported that the patient's lead had fragmented.

Manufacturer Narrative

H3: product id 97714, serial# (b)(6) was returned for product analysis.Analysis found no significant anomalies.H3: product id 3776-75, serial# (b)(6) was returned for product analysis.Analysis found the stim lead conductor was broken at the distal end.H3: product id 3776-75, serial# (b)(6) was returned for product analysis.Analysis found the stim lead conductor was broken at the distal end.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
• 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: 11038646
• MDR Text Key: 223140642
• Report Number: 3004209178-2020-22239
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• 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...."; "SEE H10...."; "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male