MAUDE Adverse Event Report: IPG MFG SWITZERLAND ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

Product id: 7489, serial# unknown, product type: extension.Product id: 3587a, lot# unknown, product type: lead.

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that the patient had ¿more pain and less/no more paresthesia in her legs and feet.¿ impedance testing was performed at 1.5 v and found that bipolar electrode pair 0-3 had an impedance of ¿>4000¿ ohms and unipolar electrode 2 had impedance reading of ¿???¿.There were no external factors reported to have contributed to the event.The patient was reprogrammed as a result of the issue and the event was resolved at the time of report.There were no surgical interventions planned or performed and the patient was alive with no injury at the time of report.

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): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6156361
• MDR Text Key: 61855990
• Report Number: 9614453-2016-06728
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2013
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Date Device Manufactured: 08/25/2011
• 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