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

Model Number 97715

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

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 manufacture representative (rep) via a patient with an implantable neurostimulator (ins) for non-malignant pain.The rep received a voicemail from the patient which indicated that when they tried to turn the stimulation up they were getting the settings not available screen.Additionally, during the day they feel like their stimulation either decreases or turns off completely.Technical services reviewed considerations for the settings not available message and programming.The rep was unsure if the patient was on high density (hd) or low density (ld) settings.The patient was not using adaptive stimulation (as).The rep did not have the entire story so it was unclear if the stimulation decreasing/turning off during the day was due to positional or otherwise.It was unknown when the issue began.The rep called back on (b)(6) 2018 indicating that they just spoke with the patient.The patient is not on hd and most days the patient is in bed or sitting.The patient feels like the stimulation is decreasing throughout the day until it is non-existent.The patient charges when the ins gets to 50% and they do so every approximately 2 d ays.The patient stated that they usually have stimulation at 13 ma.The rep had the patient over the phone decrease the stimulation below the settings not available threshold and then increased the stimulation up to 11.3 ma (11.4 ma seemed to be the settings not available spot).This level of stimulation is not what the patient prefers.The rep pulled up the patient¿s report from the programming session but only saw the stimulation at 0.0 ma.The rep is planning to meet with the patient.No further complications were reported/are anticipated.

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) on 2018-jul-19.The rep met with the patient in person on (b)(6) 2018.The rep reprogrammed the patient and was able to clear the oor.Upon speaking with the patient they stated that ¿maybe it wasn't slowly decreasing.They think it was just abruptly shutting off.¿ the rep thinks it was due to an occurring oor.The rep stressed the importance of making sure to regularly charge the ins.The patient¿s weight was unknown and would not be made available.They have not heard from the patient so they imagine that the issue was resolved.The patient is scheduled for an appointment in the future to turn on their adaptive stimulation so they will know then.No further complications were reported/are anticipated.

Manufacturer Narrative

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

• 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: 7658954
• MDR Text Key: 113246738
• Report Number: 3004209178-2018-14905
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/08/2018
• 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