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

Model Number NEU_ENS_STIMULATOR

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

Patient Problems Itching Sensation (1943); Urinary Tract Infection (2120)

Event Date 06/18/2016

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 patient reported they are itching from head to toe.They are wondering if other people experienced this during their trial with the external neurostimulator (ens).It was discussed that it is not a known adverse event.Their healthcare provider (hcp) gave them benadryl to take, which has helped some.On the day after the report he patient also reported having a uti that started on (b)(6) 2016, the day after the ens trial started.They declined to speak with a manufacturing representative (rep) and said they are already on "meds" and it was feeling better.

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

Additional information received from the consumer reported that the patient began their advanced evaluation on (b)(6) 2016.The patient passed out on (b)(6) 2016 and had been having severe itching.The patient was not sure if they were having an allergic reaction.The patient was scheduled to see their health care provider (hcp) on (b)(6) 2016.

Manufacturer Narrative

The patient code is no longer applicable to this event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a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

Additional information received from a healthcare professional (hcp) reported that no diagnostics was performed.The patient was recommended to stop new medications and start (b)(6) the cause of the itchy all over the body was not determined.It was unknown if the patient had a history of urinary tract infections (uti).The cause of the uti was unknown.The uti was not related to the device or therapy.

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5792192
• MDR Text Key: 49466148
• Report Number: 3007566237-2016-02625
• Device Sequence Number: 1
• Product Code: NAM
• 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: 08/22/2016

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: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/01/2016; 08/22/2016
• 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): Required Intervention