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

Model Number 97715

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Distress (2329)

Event Type  malfunction  

Manufacturer Narrative

Product id: 97715, serial#: (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via the manufacture representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that one of the patient's ins' intensity drops to zero when they recharge it.The patient then has to 'reset' the ins.The patient was educated on how to use the controller and to charge before the ins discharges.The patient expressed frustration that they need to be assisted with resetting intensity parameters, and not knowing what the intensity setting was.The rep was to meet with the patient at the hcp office on (b)(6) 2018 to address the issue.No further complications were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report may has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7629210
• MDR Text Key: 112568310
• Report Number: 3004209178-2018-14088
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2018
• Date Device Manufactured: 04/16/2018
• 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