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 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial#: (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

2020-feb-13 information was received from a healthcare professional, regarding a patient who was being implanted with a neurostimulator (ins).It was reported that contact 7 was out when connections were tested in ins.Contact 4 was >40000 when impedances were tested.There were no known causes.The lead was reseated 5 times and did not resolve.The hcp decided to proceed with the case stating he understood what was going on.No additional steps taken.Post op, connection and impedances were tested again with no change.The issue was not resolved.No symptoms and no further complications were reported.2020-feb-28 additional information was received from the rep.Device serial numbers were provided.No cause was given by hcp.He understood what could be causing the issue and said he was ok moving on with the situation as it was described.No further actions/interventions were taken besides what was done in the case as described.  the issue was not resolved.No further steps were planned to resolve the issue.The provided information was confirmed with the hcp.No further complications were 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9787745
• MDR Text Key: 182028960
• Report Number: 3004209178-2020-04629
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Date Device Manufactured: 12/26/2019
• 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: 74 YR