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 Pocket Stimulation (1463); Unable to Obtain Readings (1516); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: product id: 7425, serial# (b)(4), implanted: (b)(6) 1998, product type: implantable neurostimulator.The ins (serial # (b)(4)) was returned and analysis found the stimulator battery to be at normal end of life and telemetry and output were okay.The ins allegations in this event were originally coded on a different ins and the information was originally reported in manufacturer's report # 6000032-2016-00025.However, new information has determined that the device in question for this event was ins #(b)(4) and not ins #(b)(4).Therefore, all allegations and coding were moved to ins #(b)(4) and no longer apply to ins # (b)(4).No further information will be reported under manufacturer's reported # 6000032-2016-00025 and all future information will be reported under this report.

Event Description

Information was received from a manufacturer's representative (rep) regarding a patient who was implanted with a neurostimulator for failed back surgery syndrome.It was reported the patient's implant was shocking him at the pocket site.It was unknown if the patient experienced symptoms when the implantable neurostimulator (ins) was off.It was unknown if there were any trauma or falls related to the issue.It was unknown if the change in therapy was related to positional movement.The rep later reported that she met with the patient on (b)(6) 2016 and the patient noted the shocking started two to three months prior and the shocking was more intense and more frequent at the time of the report.The patient noted the shocking occurred only when stimulation was off and when he moved into different positions.The patient had no falls or trauma that lead to the issue.The shocking was located at the ins pocket site on the left side.The ins was not moving around in the pocket and did not feel like it was tilted in any way.The rep had not tried reprogramming yet because the patient was getting good therapeutic relief besides the shocking.The rep tried palpating around the ins pocket site, but was unable to illicit a shocking response.The rep noted she initially saw that the patient's ins battery was low, but after doing an impedance check, it was showing end of life (eol).However, the rep could still turn stimulation on and the patient confirmed he was feeling stimulation and it felt good.Electrode impedance was between 134-494 ohms.The patient was standing at the time.The rep noted 2 and c were showing 134 ohms and confirmed this later on the patient's print out.The rep re-ran electrode impedances after therapy measurement so she had a current and accurate reading.The rep then saw the lowest value at < 50 ohms and the highest at 494 ohms.A < 50 ohms was showing at 0 and 2.The rep ran a therapy measurement at 2.5 v and 210 pw and showed 611 ohms at 60 ma.The rep stated the patient was programmed at 0 and 3.The patient was sitting when these ran.The rep re-ran electrode impedances at 2.5 v and 210 pw while the patient was standing and got 495 ohms as the highest value, 31 ohms as the lowest value, and ??? for c/3 and 1/2.The therapy measurement was showing 643 ohms and 57 ma.The rep ran electrode impedances again using 4.0 v and 210 pw while the patient was sitting.All impedances showed within range with the lowest being 156 ohms on 2/c and the highest being 206 ohms on 0/2 and 1/3.The rep stated the ins was going to be replaced soon.Additional information received from the rep reported is was unknown if the ins was the cause of the shocking sensation.Since the ins was at eol, it was scheduled to be replaced on (b)(6) 2016.Additional information was received from the manufacturer's representative (rep) reported the patient had their stimulator replaced on (b)(6) 2016.It was noted the impedances were within normal limits with the new implantable neurostimulator (ins).The rep was going to follow up with the patient on (b)(6) 2016 to assess whether the shocking sensation had resolved.Additional information later received from the rep reported the ins had been removed due to normal battery depletion and there was no performance issue.

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; 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: 5625437
• MDR Text Key: 44352220
• Report Number: 3004209178-2016-08670
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2008
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2006
• 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
• Patient Age: 72 YR