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

Model Number	353101
Medical Device Problem Codes	High impedance (1291); Battery Problem (2885)
Health Effect - Clinical Codes	Incontinence (1928); Complaint, Ill-Defined (2331)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 3560030, lot#: va277mv, product type: extension.Product id: 3560030, serial/lot #: (b)(4), ubd: 30-apr-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) via trial patient who was using an external neurostimulator (ens) for urge incontinence and urgency frequency; the trial began on (b)(6) 2020.It was reported that the rep is currently with the patient post-op during stage 1 trial implant.The rep reported out of range (oor) on all combinations but reported 2 and 3 electrodes greater than >4,000 ohms.The caller programmed 0 and 1 electrodes with similar results but did not ask the impedance value.The caller had limited time to report to the surgeon on taking the patient back to reseat the lead/extension connection.The caller asked about replacing the ens but did report it is unlikely the cause of the impedance issues, but could try it.The following day, the patient stated they had a bowel accident in bed last night and didn't know it.The patient was really out of it yesterday and slept from 8pm to this morning.Additional information was received from a health care professional (hcp) via a manufacturer representative (rep) and a patient on (b)(6) 2020.In response to the inquiry for if the cause of the out of range combination of 2 & 3 electrodes >4000 ohms had been determined and if so what had most likely caused or contributed to the issue, the rep replied ¿yes,¿ that the lead had not been seated fully in the percutaneous extension hub.In response to what steps had been taken to resolve the issue the rep reported that the health care professional (hcp) had reopened the pocket, loosened the set screw and reset the lead in the percutaneous extension hub.The impedances were checked and they were all in range.The issue was resolved.On (b)(6) 2020, the patient reported that there was something wrong with the battery in the ens as they noticed less volume in their voids and the stream was less.The patient stated that they had spoken with their manufacturer representative (rep) whom made an adjustment and then spoke with their doctor and they agreed that there was something wrong with the ens battery.Additional information was received from a manufacturer representative (rep) on (b)(6) 2020.In response to the inquiry for clarification on the statement that ¿they noticed less volume in their voids and the stream was less,¿ and if it had meant the patient had been experiencing a reduction in therapeutic benefit and thus they had more incontinence and thus the volumes were less or if they had been experiencing urinary retention, the rep replied that the cause was not determined.The rep reported that the patient had not been experiencing urinary retention during the testing.The rep also indicated that cathing was not the patient¿s standard of care prior to the trial.In response to the inquiry for if the cause of the ¿something being wrong¿ with the battery in the ens had been determined, the rep replied ¿no,¿ and that they had checked the ens batteries at the day of the stage 2 implant ((b)(6) 2020) and the ens batteries appeared to be working as expected.In response to the request for what most likely had caused or contributed to the issue, the rep replied that the patient had been confusing the battery level in the enhanced verify programmer with the ens.In response to what steps had been taken to resolve the ¿something being wrong¿ with the battery and the patient noticing less volume in their voids and their stream being less the rep reported that the patient had been implanted with the interstim micro on (b)(6) 2020.The rep reported that ¿yes,¿ the issues had been resolved.No further complications were reported at this time.

• 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: 10659835
• Report Number: 2182208-2020-02301
• Device Sequence Number: 19625083
• Product Code: EZW
• UDI-Device Identifier: 00643169968783
• UDI-Public: 00643169968783
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 10/09/2020

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
• 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: 09/15/2020
• Initial Report FDA Received Date: 10/09/2020
• 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: Required Intervention