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 Interrogate (1332); Unintended Collision (1429); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Numbness (2415); Sleep Dysfunction (2517)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The consumer reported that they couldn¿t connect to the implant to confirm mri eligibility.The patient stated they were on group a which was at 4 point something and they weren¿t allowed to change the settings.The patient noted they fell six months after it was implanted and were having pain and they fell again on 11-june.The patient had to charge constantly and it took forever to charge so they couldn¿t use the stimulator.The patient thought the stimulator affected their nervous system as their feet were numb and tingling and the stimulation was not doing anything for them.The patient had shut the stimulator off since the fall on 11-june and couldn¿t sleep with the implant at 4 something as it was too high.Further information received from the healthcare professional reported that the patient was not shown how to use the device and received the wrong cord to charge.It was clarified that the patient had been charging but could only do it through the remote.The controller wouldn¿t find the implant to interrogate.The indication for use was spinal pain.

Manufacturer Narrative

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

Event Description

Additional information received from the patient reported that they had fallen on (b)(6) and not (b)(6).The patient stated that no steps had been taken to resolve the charging issues and the charging issues had not been resolved.

• 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: 8727374
• MDR Text Key: 149521777
• Report Number: 3004209178-2019-12192
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Date Device Manufactured: 05/24/2018
• 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: 52 YR
• Patient Weight: 59