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

Model Number 97715

Device Problems Break (1069); High impedance (1291); Connection Problem (2900)

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

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.Other relevant device(s) are: product id: 3777-60, serial/lot #: (b)(4), ubd: 28-apr-2014, udi#: (b)(4); product id: 3777-60, serial/lot #: (b)(4), ubd: 23-sep-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that during the patient¿s normal battery replacement due to eri, the physician had difficulties reinserting leads into the new ins.It was reported that the leads were swollen.It was indicated that impedances were checked prior to the procedure and were all within normal limits.However, after the leads where stationed in the new ins, when impedances were checked, electrodes 8 and 12 were greater than 4 ,000 ohms.There were no external or environmental factors that may have led or contributed to the issue.It was reported that the physician had made several attempts to reseat the leads into the new ins, and each time one of the leads (unknown which lead serial number) was inserted, between 2-8 electrodes had impedances that were greater than 4,000 ohms.It was indicated that the patient¿s doctor decided to leave the leads as is.The issue was resolved at the time of the report.No further complications were reported/anticipated.

• 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: 10267601
• MDR Text Key: 198748001
• Report Number: 3004209178-2020-12074
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/13/2020
• Date Device Manufactured: 04/07/2020
• 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: 49 YR