MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS

Model Number 97715

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

[information omitted as it pertains to a separate event; (b)(4) ¿ difficulty charging] (b)(6) 2018, (b)(4): information was received from a consumer regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that starting about a week or week and a half prior to the report, confirmed as 2018, the patient has to sit funny for the device to work and turn on.When the patient is in a vehicle and his legs start hurting, he has to reach his shoulders back and stick out his stomach and breast for the implantable neurostimulator to turn on.The patient has not had any falls or trauma.The patient had to sit or lay flat to turn the implantable neurostimulator on.There were no further complications reported.

• Brand Name: INTELLIS
• 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: 7655427
• MDR Text Key: 113182076
• Report Number: 3004209178-2018-14785
• Device Sequence Number: 1
• Product Code: NIK
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 06/28/2018
• Date Device Manufactured: 04/21/2018
• 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
• Patient Age: 45 YR