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

Model Number 97715

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

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

Event Date 03/06/2021

Event Type  malfunction  

Manufacturer Narrative

Phone number: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the ins port electrodes 8-15 did not secure the lead.Prior to impedance check, after two spinal cord stimulation(scs) leads were implanted and positioned at the desired anatomical level, the physician used a torque wrench supplied with the ins, to tighten the set screw in each port.An audible ¿click¿ was heard and impedances measured; all electrode impedances tested within normal limits.Prior to the ins implant, the physician checked the leads were secured in the ins ports by way of lightly pulling on each lead, the lead housed in the 8-15 electrode port was found not to be secured.The lead was pulled from the port without any unnecessary effort.The set screw of this port only was loosened, the lead replaced, and set screw tightened.The torque ¿click¿ was heard again, however the lead was easily removed by the physician.The set screw was loosened again, and after confirming the orientation of the set screw, an alternate torque wrench was supplied.This didn¿t resolve the issue.The lead could not be secured.The original set screw was removed from this port.It was confirmed using the wrench (put into the void created by the screw and leads removal).The original screw was then replaced.The lead was put into the port however the physician was still unable to secure the lead.Finally, the ins was replaced.Leads w ere set and ins port set screws tightened.Impedances checked and found normal.Replacement ins implanted and programmed as planned.The issue was resolved at the time of this report.The patient was alive with no injury.

Manufacturer Narrative

H6.Device analysis for ins (b)(6) revealed the set screw could not be tightened because the set screw was cross-threaded due to being backed out to far causing damage to the silicone rubber.The set screw was removed, the loose damaged pieces of silicone rubber were flushed out with ipa, and the set screw was inserted and was able to be tightened on a lead and the lead was held securely.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 11435427
• MDR Text Key: 238359267
• Report Number: 3004209178-2021-03832
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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: 11/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 03/06/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1