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

Model Number 97713

Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97713, serial#: (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Refer to regulatory report # (b)(4).The patient had two implanted systems and it was not clear which issues pertained to which implanted system.The referenced report pertains to the patient¿s other system.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that around (b)(6) 2021, the patient was getting "intermittent signals from the leads" so they were "changed", which was explained to mean they had to change which ones were on, which ones were off, and disabled one of the leads.  since those changes were made, the patient went from charging every 6 days to every 3 days, so the patient was using adhesive discs more frequently.  no symptoms reported.Additional information was received from the patient.The patient clarified that the left leg stimulation was intermittent one time.No signal for period lasting hours and then suddenly it would turn on and the stimulation was felt in left leg.The patient was unaware of any factors/circumstances that led to this.The patient also clarified the "leads were changed." they noted they were reprogrammed in closed print out of setting in 2010 and other 2021 showing changes made since then.Have had to increase amplitude to cover.Recharging went from 6 days to every 3 days, which made a big impact on their life taking 3.5 to 4 hours.

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

The patient has reported that the issue has been resolved.

• 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: 12417144
• MDR Text Key: 271281411
• Report Number: 3004209178-2021-13320
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 70 YR
• Patient Weight: 95