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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ENTERRA; NEUROSTIMULATOR
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MEDTRONIC ENTERRA; NEUROSTIMULATOR Back to Search Results
Model Number 3116
Device Problem Material Twisted/Bent (2981)
Patient Problems Pain (1994); Discomfort (2330); Weight Changes (2607)
Event Date 08/15/2014
Event Type  Injury  
Event Description
A (b)(6) year old female with history of gastroparesis and reflux.Underwent laparoscopic repair of paraesophageal hernia on (b)(6) 2014.On that date also had laparoscopic enterra lead placement 1 and 2, and placement of gastric stimulator battery.Pt returned to surgeon's office in (b)(6) 2014 complaining of pain and discomfort of placement of stimulator.X-ray revealed twisting of stimulator, pt denied twisting device.Device was functioning.Pt had gained (b)(6) lbs over past 8 months since (b)(6) 2014.Pt requested removal of device, declined option of repositioning device and replacement of leads.Device removed on (b)(6) 2014.Upon removal, battery pack noted to have been twisted in its pocket, and wires had been twisted multiple times.
 
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Brand Name
ENTERRA
Type of Device
NEUROSTIMULATOR
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55440
MDR Report Key4046912
MDR Text Key18030404
Report NumberMW5037952
Device Sequence Number1
Product Code LNQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/21/2014
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 Expiration Date07/28/2015
Device Model Number3116
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/22/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NHT021535N, BOTH WITH EXP DATE: 07/28/2015; MEDTRONIC 4351; LEADS NHT021534N
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient Weight68
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