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

Model Number 353101

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown, serial# unknown, product type: unknown; product id: 3057, lot# unknown, implanted: (b)(6) 2018, product type: screening device.All codes apply to the lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who has an external neurostimulator (ens) for urge incontinence and urgency frequency.The patient reported that her data was less than 50%, so they were going to switch sides but there was a communication error.The patient tried again, but they kept getting the same error.The next day, the patient reported that she felt a slight stinging feeling where the tape was.The patient stated that she reached back to push the tape back in place, and that is when she felt the lead wire loose.It was noted that the trial started on (b)(6) 2018.No further complications were anticipated/reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7681441
• MDR Text Key: 114545251
• Report Number: 3007566237-2018-02056
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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 Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• 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: 57 YR