MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NURO; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Model Number 3533

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Incontinence (1928); Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

A patient reported that they didn't think the therapy was doing enough because they were still having accidents all over the place.The healthcare provider (hcp) stated that maybe the 12 weekly sessions helped, but the monthly ones did not.The patient was not sure if event the 12 weekly sessions worked because they were on medications.It was noted that the hcp may have cleared up the infection the patient had in (b)(6), as they were no longer taking antibiotics.They said the therapy maybe helped a little, but it was not to their satisfaction.The patient said they think that they may be sensitive to some food that may have been irritating their bladder, and they have irritable bladder.14 ptnm therapy sessions had been completed.No further complications were reported/anticipated.

Manufacturer Narrative

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.

Event Description

Additional information received from the healthcare provider (hcp) indicated the e.Coli was treated in (b)(6) 2017.In (b)(6) 2017, 10,000 colony formed units were cultured.It was noted that their last ptnm session was (b)(6) 2017.The hcp further provide that the patient had a pelvic muscle exercise biofeedback office visit in (b)(6) 2017.There were no further complications reported as a result of this event.

• Brand Name: NURO
• Type of Device: STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
• 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: 6610176
• MDR Text Key: 76589535
• Report Number: 3007566237-2017-02149
• Device Sequence Number: 1
• Product Code: NAM
• Combination Product (y/n): N
• PMA/PMN Number: K132561
• 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: 09/08/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 3533
• Device Catalogue Number: 3533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/03/2017
• Supplement Dates Manufacturer Received: 05/30/2017; 08/16/2017
• Supplement Dates FDA Received: 09/07/2017; 09/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention