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 Charge (1085); Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that the patient had trouble charging the controller.The patient reported that instead of charging it would blink and the patient would have to remove and replace the battery pack.The screen would display "try again." patient was issued a new battery pack.Additional information received stated that the battery pack did not resolve the issue.Patient was issued a new controller.Additional information was received from the patient.It was reported that the patient recently received replacement equipment.The patient said he thinks he made a mistake with the initial setup which is causing a recharge issues where he got to 80% and could not charge further.It kept saying try again, no device found, screen 16.The patient also said the charger said finished at 80%.The patient said prior to the equipment going south, the ins always went to 100 without a problem and that was one of the reasons the equipment was replaced.The patient said he met with a person and didn¿t know if they were a manufacturer representative (rep) or a healthcare professional (hcp).This person set up a different reading enabled adaptive stimulation) and the patient no longer had the ability to change stimulation for his different body positions on his own.The patient said the equipment went south around the same time as this change.The patient positioned the recharger over the ins on the call and got excellent charging and the charge level went from 70%-90%.The patient said he tried turning stimulation off last night and it would not charge at all.The patient said it may have had to do with the amount of time between charge sessions.The issues did not reoccur during the call and the equipment functioned as intended.The patient said when he was done with the call, the person was going to reset the device.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient.It was reported that since receiving the replacement ins on (b)(6)2018, the patient has noticed a gradual change in how long it takes to charge the controller from 80% to 100%.Recharging the controller takes about an hour whereas prior to the ins replacement it would take less time than that to recharge the controller.No symptoms were reported.It was reviewed that the average time it takes to charge the controller is just over 3 hours so the controller was functioning as designed.The caller confirmed they understood this information provided.Additionally, it was reported that recharging the ins was difficult because when the patient would recharge in a recliner, the charge quality would change from excellent to poor, and then the ins would stop charging and they saw the "unable to recharge - screen 74" message on the controller.It was noted this did not happen in the past even though they were recharging in the recliner the same way.The patient had not noticed any changes to how their ins site feels and they hadn't noticed any visual changes.It was suggested to have the patient monitor and readjust the recharger the next time the patient charges the ins and take note on whether or not there is improvement in recharging as their ins site heals.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 97745, serial# (b)(4), product type: programmer, patient; product id: 97745bp, serial# (b)(4), product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that a new battery pack was sent to resolve the patient¿s issues and this did resolve the issues.The patient provided their weight at the time of the event.No patient complications were reported as a result of this event.

• 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: 7629053
• MDR Text Key: 112004135
• Report Number: 3004209178-2018-14079
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 07/06/2018; 08/08/2018
• Supplement Dates FDA Received: 06/29/2018; 08/01/2018; 10/03/2018
• Date Device Manufactured: 04/07/2018
• 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: 89 YR
• Patient Weight: 93