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); Migration or Expulsion of Device (1395); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Pain (1994); Seizures (2063); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Sleep Dysfunction (2517)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger, product id: 97745, serial#: (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).(con): information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that patient had been seeing system problem rm04, cannot continue, screen 77 and software problem (1-intellis, 2-3.0, 3-243, 4-qf_port), screen 99 when recharging the ins.The caller would reset the controller and it would go away, but the issue was persistent.No symptoms were reported.Additional information was received and it was reported that the patient got a new controller and recharger, but when they attempted to charge the controller locked up on checking recharger screen.The ins was 100% charged and the controller was 80% charged at the time of the call.When the patient attempted to connect the recharger the controller locked up on the checking recharger screen.The patient reported that they were dependent on the stimulator and wouldn't be able to function if it depleted.It was then reported that the checking the recharger issue persisted, so they were able to charge the ins and therapy depleted to off.The patient stated it put them in the hospital for pain management and it reportedly almost cost them their life (almost killed them).The patient stated that they were in the 1% of people that rely heavily on the stimulator for pain relief.They reported they were taken to the hospital when they started passing out from lack of pain relief.The patient didn't recall the day that they went into the hospital, but they were discharged and things were a blur for them.The patient asked for a new controller to be sent to them as they felt the replacement controller they were sent was defective.They further reported that a healthcare provider advised the patient to go to emergency room if something went wrong and then they could have drugs put in.The patient stated that while they were in the hospital the healthcare provider didn't have access to zubsolv, so their wife had to go get them a dose and give it to them to keep them even.They took two tablets a day sublingually.The patient also mentioned they were given shots of morphine and dilaudid every 2-4 hours.They said they stayed awake while in the hospital because they were in so much pain and were barely able to survive.The patient stated that the physician assistant didn't realize they had an ins and they manhandled their back and pushed the battery out, which caused it to go catastrophic.The patient reported that a manufacturer representative brought them a controller that worked while they were in the hospital.The patient said they were shipped a controller that was defective when the original issue was with the antenna.They added that they eventually got a repaired controller, but they were keeping the manufacturer representative's controller until they got a backup.The patient explained they didn't trust the equipment and they were awaiting a prescription for a new controller.The patient reiterated that they were sent a controller for it haphazardly charging the ins after having to reset it.The patient stated that the new equipment worked, but then they got error codes again and they couldn't charge the ins.It was reported that it was critical for the equipment to work properly because they needed to charge their ins every day and a half or they would be on the floor convulsing and passing out within 8 seconds of the ins being off.They added that they couldn't live without the ins and zubsolv combination and it worked extremely well.The patient stated that if it happened to them again they would need to have the ins taken out.The patient had been living at a 8.5 to a 9 in pain since the products were put in, however outside of the issues with the external equipment the ins had worked well for them.A manufacturer representative called in regarding the patient's concerns.They reported that the patient did not currently have issues, but they were upset about what happened previously.

• 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: 10570663
• MDR Text Key: 213180628
• Report Number: 3004209178-2020-16484
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2020
• Date Device Manufactured: 03/18/2018
• 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 Outcome(s): Hospitalization; Life Threatening
• Patient Age: 62 YR