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

Model Number 353101

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3889, lot# unknown, product type: lead.The main component of the system: other relevant device(s) are: product id: 3889, serial/lot #: unknown.Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a trial patient with an external neurostimulator (ens).It was reported that patient's lead came out and that it had dislodged and disconnected from being snagged on the toilet.Patient stated they were in pain.No further complications were reported.

Manufacturer Narrative

Product id: 3889-28, lot#: va1ntqr : product type: lead.If information is provided in the future, a supplemental report will be issued.

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: 7715764
• MDR Text Key: 115368543
• Report Number: 3007566237-2018-02199
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/04/2018

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: 07/03/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/15/2018; 08/08/2018
• Supplement Dates FDA Received: 08/24/2018; 10/04/2018
• 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: 68 YR
• Patient Weight: 65