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

Model Number 97714

Device Problems Break (1069); Difficult to Remove (1528); Delayed Charge Time (2586); Charging Problem (2892); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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

It was reported that the caller stated the patient (pt) needs an implant replacement because the rep stated "it reached its limit".Caller stated the pt will be replacing implant on (b)(6) 2023.Additional information was received from a manufacturer representative (rep).The rep met with this patient last friday with their neurosurgeon.The rep was misinformed that this patient was implanted back in 2014, which would have put the patient¿s battery at approximately 9 years.The patient mentioned that it was taking conside rably longer to recharge the device and was becoming more difficult.The rep explained to her and her husband that this may be evident with the restore device as it gets closer to end of life.After interrogating the device, the rep did not notice that the device was not in eri.The rep looked up the patient¿s implant info in mstar and noticed that she was implanted in 2016, not 2014.The rep explained to her and her physician that she my have up to two more years possibly on the device.The physician and the patient elected to have the device replaced for ease of use and decreased burden on the patient.The patient is receiving adequate relief with her device and wanted to get the device replaced sooner than later, due to her being in good health currently (elderly) and had the time available to do so.The rep was not involved with any part of this decision, as it was made between the patient and her physician.The device has not been replaced as of yet but the rep said they are happy to return it, however, there is no real complaint with it.The rep did reach out to the patient once again to make sure she understood the information that we discussed last week, including the possibility of the device having possibly two more years left of service.The patient would like to have the device replaced as scheduled by her physician.This information was discussed with the physician last friday.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that in trying to remove the lead from the implantable neurostimulator (ins), the healthcare provider (hcp) could not remove from the ins using normal force requirements.Hcp had to pull significantly hard to remove the lead.Hcp noticed some separation between contacts on the 8-15 tail along with some brownish material noted on the lead as well.They attempted to insert tail into new ins but determined the lead will need to be replaced today.Rep will send lead and ins back to for analysis.Ins replacement due to normal battery depletion.

Manufacturer Narrative

D10: section d information references the main component of the system and other applicable components is the lead.Product id 977c165 serial# (b)(6) implanted: (b)(6) 2016 explanted: (b)(6) 2023 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.

Manufacturer Narrative

Continuation of d10: product id: 977c165, serial# (b)(6), implanted: (b)(6) 2016, explanted: (b)(6) 2023, 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 manufacturer representative (rep).Rep reported that the issue has been resolved.The patient's weight is unknown.The disposition of the lead is that the account has the device and it is not in the hands of a medtronic employee.The information has been confirmed with the physician account.

• 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: 16820747
• MDR Text Key: 314072286
• Report Number: 3004209178-2023-05614
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

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 Expiration Date: 06/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/22/2023; 05/26/2023
• Supplement Dates FDA Received: 05/25/2023; 06/14/2023
• Date Device Manufactured: 07/29/2016
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female