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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 97713, lot# serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was pt stated on (b)(6) 2021 he had both ins removed. pt stated the cervical ins was shocking pt and the leads quit working on the left side about a year and a half ago.Pt stated that he would bend over and feel a shocking sensation - pt stated the rep "brent" was notified a year ago - asked unknown rep last name.Pt stated brent no longer works for medtronic.Pt stated he is working with dr smith to have the implants replaced and he wants to talk to medtronic field reps and the dm regarding the replacement - pt stated that he feels as a "returning medtronic customer" he deserves the "white glove" treatment and he wants to feel "warm and fuzzy" about going with medtronic for his pain stim implants.Pss is sending an fyi message to the field regarding pt request.Additional information was received from the rep reporting that on (b)(6) 2021 it was noted that electrode 1 and 4 were had on the thoracic unit.Bad electrodes for cervical were noted in references.The thoracic unit was adjusted for better left thigh coverage, and had the patient turn off adaptive stimulation on the cervical unit.Then on (b)(6) 2021 it was noted that both systems (cervical and thoracic) were being scheduled for removal, then mri, then implants.The patient¿s group f1 and 2 were programmed for their back and legs.Additional information was received from the manufacturer representative (rep) on 2021-09-28 reporting that the patient mentioned they experienced faulty equipment all throughout the years of having stimulators.Their scs inss were removed on (b)(6) 2021.A rep had met with the patient recently (2021-10-04) and educated them on the newest rechargeable ins.The patient was moving forward with having this ins reimplanted.

Manufacturer Narrative

Continuation of d10: product id 97713, serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type implantable neurostimulator.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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.The reason for call was pt stated the lumbar ins was removed by dr (b)(6) (b)(6) 2021 because 2 of the 6 leads quit working 2 years ago and the ins was reaching normal battery depletion pt is working with dr donald smith to have replacement ins devices put back.Pt wants to go with medtronic but he wants the field and dm to contact him to go over all of the components and make him feel "warm and fuzzy" for picking medtronic for his therapy.See related call note for request to the field to contact pt back.

• 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: 12680172
• MDR Text Key: 277863175
• Report Number: 3004209178-2021-15739
• 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
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention