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

Model Number 97712

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)

Patient Problems Burn(s) (1757); Edema (1820); Erythema (1840); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271)

Event Date 11/01/2018

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 distributor via a manufacturer representative regarding the patient who was implanted with an implantable neurostimulator (ins) for a diagnosis of lumbar disc herniation.Burns, over discharge, and symptom return were reported.Four months prior to (b)(6) 2018, the implant site of the ins began to warm up during the recharge procedure.When asked if they had noticed any abnormality with the charging system, the patient informed that the equipment did not present with any error message or icon that made them suspect a malfunction, only that the intervals between one charge had decreased from one week to one day, the process of recharging the ins was slower than usual taking about eight hours to complete a charge, and that the feeling of heat that was gradually intensifying.According to telemetry on (b)(6) 2018 with the physician programmer, it was noticed that the coupling between the recharging system and its status was fine, but the battery life was lower than expected for the programmed parameters.In the week of (b)(6) 2018, the patient suffered burns while charging the device.Images of the burns were provided.It was noted that the spinal cord stimulation therapy worked perfectly until this issue began.Tests with the recharger system, and telemetry analysis were done without results.Tests with another recharger system was done, but the issue was not resolved as of (b)(6) 2018.Symptoms included a burning sensation, pain, redness, less than 50% therapy relief, and edema.The location of the issue/symptoms was the device pocket.No medical or surgical intervention was needed to prevent a permanent impairment of function.The event did not lead to or extend patient hospitalization.The burns were a temporary injury as a result of the event, and the patient was alive.It was noted that a replacement ins was required.The telemetry printout was provided.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported that the cause of the burning sensation when recharging was not determined.The replacement of the generator was planned, but had not happened as of (b)(6) 2018 yet because the patient was going through pre-operative examinations and waiting for the insurance company approval.The distributor team was oriented to return the device to the manufacturer when the explant occurs.No further actions/interventions had occurred as they were waiting for the explant of the device.It was noted that this information was confirmed with the physician/account.

Manufacturer Narrative

Device evaluation: analysis of the implantable neurostimulator (ins) found the ins battery had reduced capacity due to overdischarge.Additionally, analysis of ins heating during recharging found there was no evidence to suggests the device behaved differently than a known good control device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H2.Correction: upon further review, d6 was known.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.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8108210
• MDR Text Key: 129085169
• Report Number: 3004209178-2018-26335
• Device Sequence Number: 1
• Product Code: LGW
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention