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

Model Number 3531

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problem Incontinence (1928)

Event Date 03/03/2018

Event Type  malfunction  

Manufacturer Narrative

Additional concomitant medical products: product id: (b)(4); lot# unknown; product type: screening device; product id: (b)(4); serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a consumer regarding a patient with an external neurostimulator (ens).It was reported that patient experienced a few accidents that were new to them.Patient got out of the car twice on (b)(6) 2018 and had large leaks without control, then had the same experience the next night.Patient also stated their bandages and wires were loose.No further complications were reported.

• Brand Name: VERIFY
• 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: 7378841
• MDR Text Key: 103747730
• Report Number: 3007566237-2018-00908
• 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
• Report Date: 03/28/2018

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: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/28/2018
• 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: 78 YR