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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 3116
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Adhesion(s) (1695); Paresis (1998); Complaint, Ill-Defined (2331)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: lead.(b)(4).
 
Event Description
The health care provider (hcp) reported that the patient was admitted to the hospital and diagnosed with gastroparesis.She also had malnutrition and intestinal adhesions from previous surgeries.Additional information received from the health care professional reported that the patient's gastroparesis was refractory to the therapy.It was noted that the stimulator was malfunctioning.The entire system was replaced.New leads were placed in the posterior wall of the stomach to prevent abdominal wall stimulation.No outcomes were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.
 
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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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5251060
MDR Text Key32194735
Report Number3004209178-2015-23445
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/03/2015
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 Expiration Date01/28/2016
Device Model Number3116
Device Catalogue Number3116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2015
Initial Date FDA Received11/25/2015
Date Device Manufactured08/05/2014
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 Outcome(s) Required Intervention;
Patient Age00021 YR
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