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); Unintended Collision (1429); Energy Output Problem (1431); Environmental Compatibility Problem (2929); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 02/24/2020

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 manufacturer representative regarding a patient who is implanted with a neurostimulator.It was reported that the patient had a fall during the week prior to the report and came into the physician¿s office on the day of the report to ensure that everything was working fine.The patient did not note any therapy changes after the fall.Impedances were tested which showed that contact 2 was greater than 40,000 ohms, but they did not check any other reference electrodes besides reference 0.The patient is programmed with standard high dose settings.Bipole, a pulse width of 200 microseconds, a rate of 1000 hertz, and the patient was feeling stimulation at 3.5 milliamps, so the patient was programmed to 3.0 milliamps on the tablet.They were able to increase groups a and c to 3.0 milliamps; however, group b would not allow the patient controller to increase stimulation beyond 2.6 milliamps as they were seeing the settings not available message.The manufacturer representative ran another impedance check which showed that contacts 0, 1, 2, and 3 may have issues.When the manufacturer representative ran an electrode impedance with reference 0, everything was normal around 1300 to 1600 ohms except for contacts 2 and 3 which were showing red x¿s at 40,000 ohms.Reference electrode 3 showed all green, but numerical values were 40,000 ohms.Reference electrode 1 showed values around 1400 ohms except for contacts 2 and 3 were 40,000 ohms.It was noted that contact 3 was active in programming.The manufacturer representative had seen the settings not available message in the past, typically with a pulse width of 90 microseconds, so they always set the pulse width to 200 microseconds and program around the impedance issues.It was suggested that the manufacturer representative reprogram around the high impedance contacts to resolve the out of regulation issue.There were no patient symptoms or complications reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that reprogramming around the high impedances resolved the issue.No further complications were reported.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9846095
• MDR Text Key: 183903766
• Report Number: 3004209178-2020-05579
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2020
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR