MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 353101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Pain (1994); Weakness (2145)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va2105e, implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 13-jul-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a trial patient regarding an external neurostimulator (ens) for urge incontinence and fecal incontinence.The patient stated she is in the hospital and she was very weak so, she cannot keep track of her symptoms.The patient said since (b)(6) 2019, she has not been allowed food or water and she might be in the hospital for a couple of more days.Addition informational reported on 2019-sept -04 from rep stated that patient was in the hospital for the last few days.When questioned why she reported that after she had lead placed (b)(6) 2019 she was having a little pain and took 1/2 norco.Physician and patient informed rep of potential adverse event after lead was removed and already discarded.Elevated heart rate and abnormal heart rhythm after interstim.Lead placed.(b)(6) the assisted living facility where she resides started noticing her heart rate was trending upwards.She reported that they were concerned about this and due to that ¿and probably a couple of other problems they have and was admitted to the hospital.¿ unknown what the other problems patient mentioned were.This was not reported earlier because patient will be seen on (b)(6) 2019 by the doctor and could get further details.Doctor informed rep that patient was in svt with heart rate in 170¿s.Physicians in hospital called to speak with him about device.Doctor denied ever having seen this reaction previously and did not believe it was from interstim device.It was the rep understanding that patient was converted in hospital to norma sinus rhythm and discharged.She was re-admitted back in svt a short time later.Decision was made to remove device and end interstim trial.Device removed (b)(6) 2019.The rep was not made aware of these events until after device was already removed and discarded by hospital.The issue was resolved at the time of this report.There were no further complications reported.

• Brand Name: VERIFY ENHANCED
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9076846
• MDR Text Key: 159120135
• Report Number: 3007566237-2019-01980
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/17/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/17/2019
• 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: 80 YR
• Patient Weight: 67