MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Overheating of Device (1437); Unable to Obtain Readings (1516)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id: 309328, lot# 0204265836, implanted: (b)(6) 2010, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported via the manufacturer representative (rep) that they woke up in the early morning hours of (b)(6) 2018 with extreme, burning pain at the implant site pocket.It was noted that the patient had an implantable neurostimulator (ins) replacement surgery the day prior to the report.When contacted by the patient, the rep advised them to turn off the stimulator and call the surgeon's room.Turning off the device settled the burning pain.There were no known factors that may have led to this issue.The patient was seen later that afternoon.An impedance check showed nothing abnormal detected expect there was no reading for c+, 1-.They attempted reprogramming, but all electrodes produced the same burning pain the device pocket.As a result, the device was left off, and the issue was not resolved at this time.It was provided that the patient was being sent for an x-ray to check the lead/ins connection as well as blood tests to check for infection.There were no further complications reported as a result of this event.

Manufacturer Narrative

Product id 309328 lot# 0204265836 implanted: (b)(6)2010 product type lead product id 309328 lot# 0204265836 implanted: (b)(6)2010 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative (rep) indicated that the x-ray appeared to have the lead appropriately seated in the header block of the stimulator.It was further provided that the lead was replaced with a new model on (b)(6)2018.The old lead was left in situ in case using the new lead did not resolve the issue.The rep mentioned that the old lead would probably be removed at a later date.The rep had called the patient on (b)(6)2018, and although they had a lot of surgical pain, they were happy to not have any of the severe burning sensation deep in the pocket site.It was indicated that the cause of the burning pain and ??? reading had not been determined.They provided that it is a common occurrence to see no reading (???) for some electrode combinations when doing an impedance check.It was of no known relevance.It often clears and gives a normal reading if repeated at higher amplitudes, but this can be quite uncomfortable for the patient.There were no further complications reported as a result of this event.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 7469793
• MDR Text Key: 106869144
• Report Number: 3004209178-2018-09514
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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: 04/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/03/2018
• Date Device Manufactured: 11/09/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR