MAUDE Adverse Event Report: SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 7427

Device Problems Unable to Obtain Readings (1516); Low impedance (2285); Battery Problem (2885); Insufficient Information (3190)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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

On 2021-jun-28, information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the pt indicated today that their ins stopped working about two weeks ago.The caller did not have an 8840 nor did the clinic so the ins could not be interrogated.Technical services (tss) had caller use the pt's 7435 and the controller did indicate that the ins battery is low--tss advised this is almost certainly normal depletion but we could not confirm this on the phone.Tss reviewed the current config of the system in context of replacement. received call back.Caller successfully interrogated ins with 8840 and impedances showed range of 452-690 ohms, none were out of range but 1-5 pair had results as question marks.Patient was using program 1 with 4- 5+ 6+ 7- and caller was able to increase amplitude to where patient was feeling stim; program 2 had been at 0v so caller turned it off completely.Therapy measurement for program 1 showed 275 ohms, 78 ua and battery information showed low, 2.17v, 89-100% capacity used.Tss reviewed battery curve and suggested scheduling replacement and that it isn't uncommon to have to increase amplitude towards end of service (eos).On 2021-july-08, additional information was received from the manufacturer representative (rep).It was reported that the cause of the question marks during the impedance reading was unknown.No actions are taken as of yet to resolve this issue; the patient was referred to his cardiologist.The managing physician will have images taken of leads to see if he's comfortable replacing the system.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• MDR Report Key: 18718275
• MDR Text Key: 336528153
• Report Number: 3004209178-2024-04930
• 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
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2008
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 02/15/2024
• Date Device Manufactured: 10/10/2006
• 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 Age: 80 YR
• Patient Sex: Male