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

Model Number	353101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Therapeutic Effects, Unexpected (2099); Cognitive Changes (2551)
Date of Event	09/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Outcome: was admitted to hospital for evaluation.Concomitant medical products: product id: 978b128, lot#: va27m45, explanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via a manufacturer representative regarding a patient that was undergoing an advanced evaluation with an external neurostimulator.The patient's medical history included overactive bladder, fecal incontinence, and radiation therapy.It was reported that the patient called the rep to tell them that they woke up at 1 a.M.Having a lot of stimulation from the device in their pelvis and all the way into their head, causing a bad headache.They then told the rep that it was making them have suicidal thoughts.They checked the stimulation level, which was set at 0.1 ma.The rep instructed the patient to turn it off.The patient said the headache did not resolve, but it was possibly getting better.The rep texted the patients physician to notify them immediately of the suicidal thoughts.The rep also contacted the police in the patient's city to request a wellness check and were told that the police would be right over.That evening the rep received a message from the physician that the patient had been taken to the hospital for evaluation and was doing okay.Later that evening, the rep received a phone call from the patient requesting that their device be turned back on.The rep explained that they would not turn the device back on that night.The rep followed up with the physician to let them know that the patient had requested the device be turned back on and that the rep was not comfort able being involved in the process.There were no device issues reported, and no further patient complications reported at this time.Additional information was received from a manufacturer representative (rep).The rep reported that the patient had all stage one implants removed on (b)(6) 2020.

• Brand Name: VERIFY ENHANCED
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10645058
• Report Number: 2182208-2020-02262
• Device Sequence Number: 2604583
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR