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

Model Number 97715

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Impedance Problem (2950)

Patient Problem Electric Shock (2554)

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 manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was patient reports shocking/jolting every 3-4 seconds with therapy on.Can confirmed that with therapy off patient does not feel symptoms.Last time patient was seen the only changes to programmer were cycling for 30 min on and 15 off to conserve battery life.No trauma or environmental interference reported.The caller was not with the patient.Ts reviewed to meet with patient to interrogate to investigate further.Impedances can be checked, certain positions, palpation, and imaging can help provide more information.Patient may meet with rep today if they can make it into office.

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.

Event Description

The manufacturer representative met with the patient for troubleshooting on (b)(6) 2021.An impedance check showed electrodes 1 and 5 as having a possible short.The manufacturer representative reprogrammed avoiding electrode 5 which had been in use and stimulation was back to a comfortable sensation with no reported loss of coverage and no jolting.Upon a subsequent impedance check impedances showed within normal range/all green.Another impedance check showed all in range/green but electrode 14 showed a number in the 20,000s which was elevated from the rest.A subsequent impedance check suggested avoiding electrodes 1, 5 and 14.A subsequent impedance check showed impedances within range/green.Impedances appeared to be intermittently out of range; i was not able to isolate the appearance of out of range electrodes with a specific position.The cause of the shocking is unknown.The lead was implanted in 2007.As of now, the original issue of shocking is resolved as the manufacturer representative was able to reprogram without using electrode 5.Electrodes 1 and 14 were not previously or currently in use.

• Brand Name: INTELLIS
• 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: 11807762
• MDR Text Key: 250807202
• Report Number: 3004209178-2021-07553
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 130