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

Model Number 97715

Device Problems Material Frayed (1262); Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id: 97755-s, (b)(6),: product type: recharger section d: information references: the main component of the system.Other relevant device(s) are: product id: 97755-s, serial/lot #: (b)(6).H3: analysis of the 97755-s recharger (rtm) (b)(6) revealed frayed insulation on cable, as well as recharger antenna failure due to controller goes blank when rtm is plugged in.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was caller reported that there is some damage on the recharger cord near the relay box; looks frayed.Caller stated they were trying to charge the implant and it was not connecting and seemed like there was a short so that is when they inspected it and noticed the damage.Agent did not ask about the circumstances that led to the reported issue.

Event Description

Additional information was received from the patient (pt).They reported that the issue has been resolved.

Manufacturer Narrative

Continuation of d10: product id 97755-s lot# serial# (b)(6) implanted: explanted: product type recharger medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19061902
• MDR Text Key: 339618944
• Report Number: 3004209178-2024-08662
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000315467
• UDI-Public: 00763000315467
• 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,Followup
• Report Date: 05/17/2024

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 Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/24/2024
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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
• Treatment: "SEE H11"
• Patient Age: 71 YR
• Patient Sex: Male