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

Model Number NEU_ENS_STIMULATOR

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

It was reported that a few hours ago today the wire (lead) that was connected for the trial became damaged/severed as the patient was changing clothes.The patient had two sides and was told to stay on this side initially.The patient left a message at her health care providers (hcps) office and had not received a call back.It was reviewed that the option may have needed to consider at that point was to switch to the other side and then get further direction from the hcp when became available.The patient ended up speaking with her hcp and she switched to the other side and was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Follow up information confirmed that the right lead started to malfunction so the patient was switched to the left lead which worked well.The patient recovered without permanent and was reported as doing fine.If additional information is received, a follow-up report will be sent.

• Brand Name: UNKNOWN NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4806256
• MDR Text Key: 5926192
• Report Number: 3007566237-2015-01489
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• 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