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

Model Number 97715

Device Problems Energy Output Problem (1431); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that it had been taking a long time for them to recharge their ins.Pt said they have to charge their ins 3 times a day, during the day will have stimulation at 5 and at night turns it down to 3 (pt said when it is at 5 they don't feel the throbbing or the impulse, pt used to have stim at 6).Pt said when they turn it down to 3 it will drain 20% of their battery.Pt said when they look at the batteries while recharging, the controller battery will go from 100-90% while the ins battery will go from 60-70%.Pt said they don't want to sit for 2 hours a day to recharge and if they move a little bit, their recharge quality will go from excellent to good.  pt said they are going to look into having a new device put in.Patient services (pss) reviewed that the different intensity settings may affect how much the battery drains during the day and redirected back pt to the rep to pull recharging diagnostics on the ins.The patient was redirected to their healthcare provider to further address the issue.

• 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: 11664520
• MDR Text Key: 267437438
• Report Number: 3004209178-2021-05987
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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: 04/09/2021
• Date Device Manufactured: 03/24/2020
• 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