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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Application Program Problem (2880)

Patient Problem Pain (1994)

Event Date 07/24/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 31-aug-2022, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 28-aug-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A friend/family member reported that around (b)(6) 2021 the patient had fallen twice within 30 minutes, and then fell again on (b)(6) 2021.  since the fall in (b)(6) 2021, the patient had been experiencing a sharp penetrating pain that went from their back to their chest when they moved a certain way.  x-rays were taken because they thought the patient had broken a rib, but the results showed that the rib was not cracked.  the caller thought that one of the leads came loose.  on (b)(6) 2021, they tried to make changes to the settings and the controller displayed the settings not available message.  it was confirmed the ins had a 100% charge.  patient services reviewed to lower stimulation in other groups and/or programming changes.  they were redirected to the doctor to check the implanted devices.

• 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: 12288692
• MDR Text Key: 265423270
• Report Number: 3004209178-2021-12028
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/06/2021
• Date Device Manufactured: 09/05/2018
• 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: 51 YR