MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 7425

Device Problem Battery Problem (2885)

Patient Problem Incontinence (1928)

Event Date 08/29/1994

Event Type  Injury  

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 an implantable neurostimulator (ins) for unknown indications for use.Information was received from a patient (pt) regarding an implantable neurostimulator (ins).Patient reported he met with mdt rep 5-6 months ago and rep checked the implant and ins is dead.Patient services (ps) confirmed ins is depleted due to normally battery depletion.Patient reported he did not get a lot of relief from the therapy almost right away after the implant, when he increased the stimulation his bowel would let loose.Patient stated he had the implant in 1994 and had a revision in 1996 and after the revision he had no relief from the therapy and had several reprogramming done but it didn't help.Patient stated he is seeing a dr rascalava at revive pain and spine center but he is not sure hcp name.Patient did not have rep name that checked his implant.The reason for call.Patient stated his hcp ofc wants to do a mylogram of his neck but he wants to have an mri instead and like to know if he is able to have an mri.Patient stated the ins is dead.Patient asked if he had the ins remove but kept the leads or have all the equipment remove if he would able to have an mri.Ps reviewed information.

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12699197
• MDR Text Key: 278414764
• Report Number: 2182207-2021-01870
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• 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: 31 YR