MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Electromagnetic Compatibility Problem (2927)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

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 spinal pain.It was reported that the patient was using a vibrating hot pad on their back when they suddenly felt stimulation "shoot up high" and was affecting the patient's feet.The patient turned the ins off.The caller was ready to turn the ins back on today and they let a voicemail for their rep, but had not heard back yet today.Patient services reviewed the use of the patient programmer and screen meanings.The patient believed the ins was set at 2.6 or 2.8  prior to the event and the current setting was 2.8.The patient decreased the settings to 1.9 then turned stimulation on.The patient stated that they felt stimulation in their left leg which was not present before.They decreased to 1.7 and th ep no longer felt this stimulation.The patient stated that they would need time to know if this was resolved.Patient services reviewed programming options and stated that they could call back if needed.The patient was redirected to their healthcare provider (hcp) if the issue continued.The patient also inquired if cycling would be active again and patient services redirected them to their hcp if the cycling did not continue as normal.

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

Additional information was received from the patient and it was reported that the patient is sure the cause of the stimulation shooting was the heating pad.When the manufacturing representative (rep) checked it over, all systems are a go on the stimulation.The patient will not use the heating pad again.The issue is partly resolved as the patient and rep are not sure if the settings are correct.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10930990
• MDR Text Key: 219191111
• Report Number: 3004209178-2020-20941
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• 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: 01/19/2021

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: 01/28/2014
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR