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

Model Number 97715

Device Problems Unable to Obtain Readings (1516); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2019

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 representative (rep) and confirmed by the physician regarding a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that on (b)(6) 2019, the rep went to an ins replacement (no device issue was reported) and in pre-op they tested impedances on the new ins with the following programming: -0 3+, -4 7+, 210 us, 30 hz.It was noted the patient's programming was only using contacts 0, 3, 4 and 7.The impedance readings were the following: 0,1 ???; 0,2 1442; 0,3 1442; 0,4 1442; 0,5 ???; 0,6 1442; 0,7 1442; 1,2 714; 1,3 1442; 1,4 1442; 1,5 714; 1,6 1442; 1,7 1442; 2,3 ???; 2,4 ???; 2,5 714.It was noted the impedances also had "15" after them.No symptoms were reported.The rep confirmed they would not be using contacts that appeared with "???" in the impedance reading, so they were not concerned about that, and explained the patient would be using the same program.Technical services explained that the ??? appeared due to a software issue, and that the impedances used in the patient's programming were within normal range.It was also suggested the rep check impedances again after increasing pulse width and then to test at 3 volts or 4 volts.After increasing pulse width and increasing the voltage to 3v or 4v, the impedances still did not resolve, however it was confirmed that the patient was receiving effective therapy.No further complications were reported or anticipated.

Manufacturer Narrative

Correction: there was no issue with the device listed in this regulatory report.This report was submitted in error.The device information was corrected and a regulatory report was submitted under report#: 3004209178-2019-20535 containing the proper information.Any future follow up reports will be submitted under regulatory report#: 3004209178-2019-20535.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.

• 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 MN 00777 1200
• MDR Report Key: 8489725
• MDR Text Key: 145621336
• Report Number: 3007566237-2019-00820
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR