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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR
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MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number NEU_ENTERRA_INS
Device Problems Energy Output Problem (1431); Environmental Compatibility Problem (2929)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient drove over a bridge and received an increase in voltage stimulation.It was noted that the patient had the device for 3 years.No further complications were reported/anticipated.
 
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Brand Name
ENTERRA
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 Key8531494
MDR Text Key142488586
Report Number3007566237-2019-00899
Device Sequence Number1
Product Code LNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNEU_ENTERRA_INS
Device Catalogue NumberNEU_ENTERRA_INS
Was Device Available for Evaluation? No
Date Manufacturer Received04/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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