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

Model Number 7425

Device Problem Break (1069)

Patient Problem Dizziness (2194)

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3587a, lot# lc0407, implanted: (b)(6) 2004, product type: lead.This event was previously reported in manufacturer's report # 3004209178-2010-00508.Any additional information received regarding this event will now be reported through this manufacturer's report.

Event Description

Information was received from a manufacturer representative and a patient who was implanted with a neurostimulator for failed back surgery syndrome.It was reported that the month prior to the report, the health care provider did a x-ray and confirmed that the lead was broken.The health care provider did not want to remove it due to the risks.The patient stated that she gets dizzy from using stimulation.The patient was going to follow-up with her health care provider regarding a solution for the long term.Additional information was received from a manufacturer representative on 2010-06-25 that reported that the old "bad" lead that was implanted on (b)(6) 2004 remained in place and implanted.

Manufacturer Narrative

Corrected information: sex, date of birth.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; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5885362
• MDR Text Key: 52395559
• Report Number: 3004209178-2016-17089
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2007
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2016
• Date Device Manufactured: 04/10/2006
• 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