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

Model Number 97715

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problems Pain (1994); Discomfort (2330); Cognitive Changes (2551)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.Pt states she has lost her controller and has looked all over and believes it was stolen.The patient stated she wanted to use her controller because she was having extra pain and realized it was nowhere to be found.Pt had stated that last night felt achy and normally charges before going to bed and that's when she realized controller was gone.Additional information was received from the patient.The patient said they were "in so much pain" and "it hurts to move" as the ins had depleted due to misplacing the equipment.The patient then expressed their pain was so severe that they were suicidal.The patient called back later and reported they recently got a replacement controller but they hadn't been able to use her equipment because the controller didn't seem to charge so they weren't able to charge the ins.The patient stated the date and time was also wrong on the controller.The patient had the controller plugged in for several hours and the green flashing light that indicated the controller was charging would intermittently turn off so the patient would need to unplug and plug the controller back in.The patient stated the light would stop flashing about every half hour and she had to unplug/re-plug the cord 3-4x.During the call, the patient encountered a no device found message then the message indicating the controller battery was too low to start a passive recharge mode.The patient plugged the controller into the power cord and confirmed the green light was flashing indicating the controller was charging.After about 10 mins, the patient attempted a prm again but reported seeing a message indicating the controller's battery is "low" then screen 49 - recharging excellent.The controller battery level was "orange" and the ins battery level was "red".It was recommended for the patient to finish charging the controller to 100% then charge the ins.It was reviewed that the date/time can be changed when there is not active charging session of the ins.The patient mentioned the ac power supply cord seemed a bit loose, and mentioned the rtm may be loose too.An ac power supply cord was sent to the patient to address the controller intermittently charging.It was recommended for the patient to call back for further troubleshooting once the controller is charged, if desired/needed.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10620861
• MDR Text Key: 209626665
• Report Number: 3004209178-2020-17143
• 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
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Date Device Manufactured: 03/17/2020
• 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 Outcome(s): Life Threatening
• Patient Age: 53 YR