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

Model Number 3531

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Reaction (2414)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 3889, implanted: (b)(6) 2018, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3889.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an external neurostimulator for urge incontinence.It was reported that the patient experiences a lot of issues with tape and she experienced a lot of bleeding the day before the report because the healthcare professional (hcp) had to use a glue rather than a tape in order to prevent her from getting blood blisters from the tape.On (b)(6) 2018, additional information was received that the patient thought the wires had pulled out or moved as the wire was just hanging there.The patient was advised to contact the healthcare professional (hcp).The patient also mentioned having an allergy to tape, so the device was not tapped due to her forming blood blisters.The patient believes the wire may have moved or became dislodged because her symptoms were returning and she was also in a lot of pain.The stimulation was increased and she was much comfortable.It was noted that the patient has left a message for her hcp.On (b)(6) 2018, it was further reported that there was a thick scab where the leads were that causes her pain when she bends over.The patient will be seeing her hcp on (b)(6) 2018.There were no further complications or anticipations reported with this event.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 3889: product type:lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Healthcare provider (hcp) responded to a letter.When asked what actions/interventions were taken to resolve the wire issue and return of symptoms, the hcp said they met and new bandages were placed securing the external wires.No further patient complications have been reported as a result of this event.

• 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: 7702073
• MDR Text Key: 114722971
• Report Number: 3007566237-2018-02150
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 06/19/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/24/2018; 08/08/2018
• Supplement Dates FDA Received: 08/28/2018; 10/03/2018
• 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: 70 YR
• Patient Weight: 93