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

Model Number	97715
Medical Device Problem Codes	Material Frayed (1262); Overheating of Device (1437); Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date is approximate.Analysis of the recharger (serial# (b)(4)) found that the cable was cut at the entrance to the donut.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that when the patient was charging the ins the controller screen flashed an "emergency message" and said to call mdt.The patient stated then the screen went blank and now they couldn't get the message to appear again, but they had resumed charging the ins.It was later noted that the controller displayed a software problem message.A replacement controller was sent to the patient.The patient also reported that they had been having difficulties charging the ins because the recharge quality drops from excellent to poor without them moving.The patient stated that this caused them to charge up to 2-3 hours a time.The patient also mentioned that when the recharging difficulties started they noticed that the recharger (rtm) got so hot it "burns" them and was burning their skin.The patient said they had to put a cloth between the rtm and their skin.The rtm cord was frayed at the entrance to the doughnut.A replacement rtm was sent to the patient.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Review of the previous report found the recharger (serial# nlf033166n) was incorrectly reported as a single device but is part of a system.Current report updated to include the ins.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Common Device Name: 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
• MDR Report Key: 8926554
• Report Number: 3004593495-2019-00867
• Device Sequence Number: 13516306
• Product Code: LGW
• UDI-Device Identifier: 00613994925985
• UDI-Public: 00613994925985
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 11/20/2019; 11/20/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 11/20/2019; 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR