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

Model Number 3531

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Therapeutic Effects, Unexpected (2099)

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3057, serial/lot #: unknown.(b)(6).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 urgency frequency.It was reported that the patient no longer felt simulation at any level and believed her leads had moved.The patient stated that she turned on her programmer and there were no connection issues.It was noted that the patient was lifting heavy objects.On (b)(6) the patient reported that she had some bleeding and blood on her pajamas in the morning.The patient noted that she thought the leads may be loose because she was not feeling stimulation.On (b)(6) the patient reported that she had been in the hospital for the last 2 days.The patient did not specify a reason, however, she mentioned that she would be continuing the evaluation and hopefully now it wouldn't hurt so much.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the hospitalization was not related to the device/therapy and the leads mi rated.The health care professional also noted that the issues resolved and the patient initially had a successful trial.There were no further symptoms or complications reported or anticipated.

Manufacturer Narrative

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

• 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: 7753931
• MDR Text Key: 116205410
• Report Number: 3007566237-2018-02317
• 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,health professional
• 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: 3531
• Device Catalogue Number: 3531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/17/2018; 08/08/2018
• Supplement Dates FDA Received: 08/21/2018; 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 Outcome(s): Hospitalization
• Patient Age: 69 YR