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

Model Number 97714

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

Patient Problems Dyspnea (1816); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer representative (rep) reported that the healthcare provider (hcp) was going to explant the implanted neurostimulator (ins) and lead on (b)(6) 2021.  the reason for explant was unknown at the time of the report, but the nurse was going to check with the physician.  no symptoms reported.  additional information was received on august 11, 2021 from the rep and the healthcare provider (hcp).It was reported that on (b)(6) 2021 the patient informed them that their implanted neurostimulator (ins) that was implanted in 2016 was not working, which was explained to mean that it was not effective because it was providing inadequate pain relief for "some time", so they had stopped using it in the past "couple of years".It was also causing them pain at the ins site when they were in different positions and because they would bump the ins site.The patient was going to have the ins removed on (b)(6) 2021 but the clinic does not do general anesthesia, which the physician believed the patient would need during the procedure.The rep reported the surgery was aborted because the patient was having spasms and some difficulty catching their breath.The physician plans on referring the patient to a surgeon; most likely the implanting physician to discuss removal.The patient hadn't mentioned any factors or circumstances that may have caused or contributed to the reported issues.Patient weight was provided.

Manufacturer Narrative

Continuation of d10: product id 39565-65 lot# 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.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) reporting that the patient indicated their device had not been providing adequate pain relief for 1 year.There were no contributing factors reported.It was clarified that the patient¿s symptoms of ¿spasms and difficulty catching their breath¿ were a reaction to the anesthesia.It was indicated that the spasms and difficulties breathing resolved.The patient had not yet been referred to a surgeon yet to reschedule their surgery.

• 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: 12316587
• MDR Text Key: 266379217
• Report Number: 3004209178-2021-12345
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 90