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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Overheating of Device (1437); Therapeutic or Diagnostic Output Failure (3023); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2019-nov-26, (b)(4): information was received from a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that in the past few days prior to the report, after she was done charging her implantable neurostimulator (ins) the controller would display the ¿settings not available¿ message.The patient stated that one night she charged and then the next morning, her controller said, ¿settings not available¿.The stimulation was shut off on one side and the other side had decreased settings from where they were usually at.The patient noted that she kept her settings high (usually 10) for each group, but one group was "stuck at 7.5".The patient wondered if this was happening because she thought that her device was possibly "overheating." in the end, the patient was redirected to follow-up with their healthcare professional (hcp) to address adjusting the patient¿s settings.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer reported that they were going to have an appointment with their doctor on (b)(6) 2020.The patient stated that the controller had locked up three times and they had to remove the battery to get it to work again.The patient noted that the removing of the battery rest the device and resolved the issue, but they had done it three times now.The patient was waiting to see their doctor to try to resolve it.

• 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: 9418287
• MDR Text Key: 178631880
• Report Number: 3004209178-2019-23192
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Date Device Manufactured: 09/05/2017
• 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: 52 YR
• Patient Weight: 68