MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Twitching (2172); Cramp(s) (2193); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information received from the consumer via the manufacturer representative (rep) reported twitching, cramping, and suspected fluid short.It was reported that they think that the neurostimulator may be malfunctioning.Apparently, it was thought that their leads were faulty but during surgery, they found their stimulator was shorting out so needed a whole new device.The patient was experiencing a strong twitch/cramp in their abdominal muscles that was very visible and causing pain.It also gave them a shocking feeling.When the surgeon checked the device, it says things were fine.The higher the settings go on the device, the worse the feelings were and the less it helped their symptoms.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

Information received from the consumer via the manufacturer representative (rep) reported twitching, cramping, and suspected fluid short.No further complications were reported/anticipated.

• Type of Device: INTESTINAL STIMULATOR
• 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: 7570958
• MDR Text Key: 110169251
• Report Number: 3007566237-2018-01700
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• 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
• Report Date: 06/05/2018

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: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 05/14/2018
• Supplement Dates FDA Received: 06/05/2018; 06/05/2018
• 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): Required Intervention