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

Model Number 97715

Device Problem Impedance Problem (2950)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3487a-56, lot#: v400923, implanted: (b)(6) 2010, product type: lead.Product id: 3487a-56, lot#: v396202, implanted: (b)(6) 2010, product type: lead.Other relevant device(s) are: product id: 3487a-56, serial/lot #: (b)(4), ubd: 29-jan-2014, udi#: (b)(4); product id: 3487a-56, serial/lot #: (b)(4), ubd: 22-jan-2014, udi#:(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient had burning pain with certain movements some of the time while using the stimulator.It was found that increased impedance was found on electrodes 4 and 15 neither or which were in use on any program.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12045786
• MDR Text Key: 257592827
• Report Number: 3004209178-2021-09774
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Date Device Manufactured: 02/29/2020
• 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: 72 YR