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

Model Number 97715

Device Problem Electro-Static Discharge (2149)

Patient Problem Pain (1994)

Event Date 09/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer about an implantable neurostimulator (ins) implanted for non-malignant pain.It was reported that the patient was seeing " software problem" screen reported saturday.They tried troubleshooting with the rep the next day.They had been in "bad pain" since saturday with the bad rain and lightning today when the patient plugged the controller into the ac power supply without the li battery.They reported they saw the "data has been lost- memory has been lost" screen.The rep suggested replacing the controller.No medical or therapy problem was associated.No out of box failure was reported.No symptoms were reported.No further allegations/complications were reported.

Event Description

They called on september 10th, and repair stated they thought that the patient was confused about charging.They had aa batteries installed and were attempting to charge them.The ii-ion pack was dead, will call patient in an hour to resume testing.They telephoned the patient back, recharger was at 70%, resumed testing, unit began charging her implant at 60%, everything functioning normal.They advised the patient to charge her ptm when not charging her implant.No equipment sent, as they were given advice only.No out of box failure was reported.No further allegations complications were reported.

Manufacturer Narrative

Concomitant medical products:¿ product id 97745 lot# serial# (b)(4), implanted: explanted: product type programmer, patient.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 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: 9164138
• MDR Text Key: 168460605
• Report Number: 3004209178-2019-19155
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR