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 Urinary Tract Infection (2120); No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer, who started treatments on (b)(6) 2016, reported having a urinary tract infection (uti) around christmas and was on her third set of antibiotics.The consumer was going to follow-up with her healthcare professional to see if there was a way to get rid of utis without taking antibiotics.It was noted that the consumer had had chronic utis for the past eight (8) years, had been on/off amoxicillin and other antibiotics for the past eight (8) years, and took 250 (?) of amoxicillin in the morning, a probiotic at noon, and amoxicillin again at night.It was also mentioned that the consumer had terrible leg cramping but this started way before therapy.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the manufacturer¿s representative (rep) reported they were contacted by the healthcare provider¿s office who told them they felt the urinary tract infections had nothing to do with the external neurostimulator (ens) since the consumer had a history of them prior to treatment.

Event Description

Additional information from the patient reported they had really bad bronchitis in the month of (b)(6) again.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6283777
• MDR Text Key: 65970622
• Report Number: 3007566237-2017-00338
• Device Sequence Number: 1
• Product Code: NAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2017

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: 01/24/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/10/2017
• Supplement Dates FDA Received: 02/08/2017; 05/03/2017; 09/29/2017
• 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
• Patient Age: 82 YR