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); Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 08-sep-2024, udi#: (b)(4).Product id: 977a260, serial/lot #: (b0(4), ubd: 08-sep-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was reported that high impedance was observed on second electrode from channel port.There were no known factors related to this.Several impedance checks, switching channels, wiping off and cleaning several times.High impedance followed the electrode to each channel.The rep was unable to resolve the impedance issue, but the lead was implanted successfully.The issue was deemed resolved at the time of the report.Additional information was received from the manufacturer representative (rep) reporting that the cause of the high impedance issue was not determined.It was indicated that post-op programming was able to cover the patient¿s pain without using the electrodes with high impedances.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.Additional information was received.It was reported the high impedance was >40,000 ohms.

• 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: 10929814
• MDR Text Key: 219378410
• Report Number: 3004209178-2020-20934
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Date Device Manufactured: 08/31/2020
• 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: 77 YR