MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Battery Problem (2885); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with a neurostimulator (ins) for post lumbar laminectomy syndrome.Patient called and were asking the max "frequency" for device.Patient was trying to tell how many times they could press it and it will go up.Patient stated that they were up to 58 that they pressed it, so they were trying to figure out if they were at the maximum voltage.Patient stated that they trying to figure out what's going on because they had a pain block a few weeks ago in which they turned the ins off.During the procedure, it came back on.When patient got home from the pain block procedure, the device was on, and since then, device had been acting up.Patient stated that during procedure, they did a lot of x-rays and things like that, but the ins had never done that before, stating they usually turned ins off before x-rays.Following the pain block procedure, when patient got to (b)(6), patent stated that "it was killing me" and had to keep turning ins up.Patient confirmed that pain block and x-rays were not related to device/therapy.Patient's old managing hcp had moved and they were not sure of who their new managing hcp was.No further complications were reported/anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3487a, lot#: j0220165v, implanted: 2002 (b)(6), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that the cause of the device turning on during pain block procedure was not determined.The battery was confirmed to have died and will be replaced including the cable along the spine (lead).The replacement was scheduled for early (b)(6) of 2018.Patient's weight and hcp information was provided.No further complication were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7067470
• MDR Text Key: 94197263
• Report Number: 3004209178-2017-24522
• Device Sequence Number: 1
• Product Code: LGW
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2020

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: 04/14/2012
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 12/18/2017; 10/27/2020
• Supplement Dates FDA Received: 01/03/2018; 10/27/2020
• Date Device Manufactured: 10/18/2010
• 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: 67 YR
• Patient Weight: 39