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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 37800
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Hernia (2240)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 4351-35, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient went in to the hcp office over the past weekend due to lead wire displacement; the wire had retreated from the stomach wall.The hcp also mentioned there was a ventral hernia.No further complications were reported.
 
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Brand Name
ENTERRA
Type of Device
INTESTINAL STIMULATOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7614843
MDR Text Key112202531
Report Number3004209178-2018-13769
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00643169360686
UDI-Public00643169360686
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 health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2017
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2018
Date Device Manufactured03/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age49 YR
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