MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97725
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), product id: 977d260, serial/lot #: (b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a manufacture representative (rep) regarding a patient with a wireless external neurostimulator (wens) for an unknown indication for use.It was reported that the rep reported getting four to five electrodes on each lead that were out during the connectivity check.It was reported that the healthcare provider (hcp) tried wiping down the lead and then reinserting it.However, when the rep checked the impedances again everything was still out, although they stated that some gave them ¿orange¿.The hcp then proceeded to move the needle, but things were the same.The rep stated that the hcp then replaced the wens and they had the same impedance issue.The hcp then replaced the lead and the connectivity was then great and the impedances were within limit.It was discussed the potential for temporary high impedances when there is a loss of resistance used with air, as well as sterile water.It was reviewed with the rep that it was not unusual to encounter temporary high impedances due to air.If the hcp knows that the lead placement was good, then they could choose to leave the lead as is, but it was up to them to replace the equipment at this point.Technical services also suggested running the patient¿s stimulation for some time to see if stimulation would drive down the impedances.No symptoms were reported.It was reported that the event occurred on (b)(6) 2018.No further complications were reported/anticipated.Additional information received from the manufacturing representative (rep) indicated that the cause of the impedance issue was not determined.It is possible that there was an air bubble in the epidural space.The rep stated that after the leads and wens were replaced, the impedances were found to be within normal limits for all electrodes.The issue was resolved and confirmed with the account.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis of the leads vaiubgx039 and vaiusq7035 was done and no anomalies were identified.The leads passed all testing in the laboratory.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8061303
• Report Number: 3007566237-2018-03295
• Device Sequence Number: 16640968
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2020
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR