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

Model Number 97715

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37714, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: implantable neurostimulator.Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 06-feb-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who is implanted with a neurostimulator.It was reported that on (b)(6), during an ipg replacement, 8-15 lead was stuck in 37714.When finally removed from old ipg lead appeared intact, but would not advance into 97715.Additional information was received from a manufacturer representative regarding the patient on 2020-jul-21.The reason for the replacement was due to end of service of the 37714.The cause of the lead being stuck in the old implantable neurostimulator and not advancing into the new implantable neurostimulator was not determined.The lead is still implanted, and it is to be determined whether or not it can be used.It showed high impedances during intraop testing when it was advanced into the implantable neurostimulator as far as it would go.There were no patient symptoms or complications reported.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10318243
• MDR Text Key: 200439165
• Report Number: 3004209178-2020-12749
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Date Device Manufactured: 05/05/2020
• 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: 71 YR