MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3023

Device Problems Electromagnetic Interference (1194); Energy Output Problem (1431)

Patient Problems Apnea (1720); Dyspnea (1816); Fall (1848); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Weakness (2145)

Event Date 06/12/2019

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 healthcare professional (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient went through a courthouse metal detector on (b)(6) 2019, and since then, the ins had been firing too much and the patient felt weak on the left side even though the ins was on the right side.The patient was going up stairs, fell, had breathing issues and brief respiratory arrest, and was brought to the emergency room on (b)(6) 2019.Everything was fine at the time of the call with the manufacturer's technical services on (b)(6) 2019; the patient was talking, bright, alert, and their statistics were stable, but the patient still felt overstimulated and weak on the left side.The patient had the patient programmer, but didn't have the right batteries for it.It was noted that they believed the stimulator was on.The ins firing too much had persisted since (b)(6) 2019.It was noted that the patient was seen by a hcp in (b)(6) 2019, and the patient's next appointment was in (b)(6) 2019.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8755858
• MDR Text Key: 149916073
• Report Number: 9614453-2019-02160
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2019

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: 05/28/2017
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/02/2019
• Date Device Manufactured: 12/10/2015
• 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): Life Threatening
• Patient Age: 44 YR