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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 Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Abdominal Pain (1685); Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 435135, serial (b)(4), implanted: (b)(6) 2010, product type lead.Product id: 435135, serial (b)(4), implanted: (b)(6) 2010, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that a patient started getting shocking sensations.The hcp tried to adjust the patient's battery two different times to alleviate the shocking, but had no success.They took the patient to the operating room (or) on (b)(6) 2017 and replaced the patient's leads.The hcp later noted that when they were replacing the leads, they noticed that it looked like there may be a little area on the lead that was worn through causing them shocking.The rep noted that the patient had their battery replaced on (b)(6) 2017, so the patient had a new battery and new leads.The patient was going well up until (b)(6) 2017 and they had another episode of shocking with abdominal pain at the site.The patient was at 7 voltage which was the same prior to the operation.They said their pain was not positional, they had it while lying down.It shocked the patient and then repeated several times thereafter through the night.Impedance was at 450.On 2017-sep-06 additional information from the rep stated that the patient had said they didn't fall, but then it slipped their mind that they tripped over the dog scuffing their left knee and hurting their ankle on the left side, however there was no indication that it was at all related to the device or therapy.The hcp also mentioned that they thought the voltage on the battery, which was set to 20 current, 7 voltage, might be too high for the battery.On 2017-sep-13 additional information from the rep reported the hcp turned down the patient's voltage and they had not heard back from the patient since.They were hoping it fixed the issue.No further complications were reported/anticipated.
 
Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 4351-35 lot# serial# (b)(4) implanted: 2017 (b)(6) explanted: product type lead product id 4351-35 lot# serial# (b)(4) implanted: 2017 (b)(6) explanted: product type lead product id 435135 lot# serial# (b)(4) implanted: 2010 (b)(6) explanted: 2017 (b)(6) product type lead product id 435135 lot# serial# (b)(4) implanted: 2010 (b)(6) explanted: 2017 (b)(6) product type lead: evaluation conclusion code 22 applies to leads (b)(4); patient codes (b)(4) apply to leads (b)(4); device code (b)(4) applies to (b)(4) evaluation conclusion code 92 applies to leads (b)(4); patient codes (b)(4) applies to (b)(4); device codes (b)(4) apply to leads (b)(4).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
Additional information from the hcp reported the event of shocking began on 2017-aug-11.The voltage on the new battery, prior to the lead replacement was returned to the previous setting.The new generator battery current was much increased, likely causing the shocking.No further complications were reported/anticipated.
 
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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 Key6879048
MDR Text Key86754946
Report Number3004209178-2017-19695
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00643169614246
UDI-Public00643169614246
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,Followup,Followup
Report Date 11/22/2017
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 Date12/14/2018
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2017
Initial Date FDA Received09/20/2017
Supplement Dates Manufacturer Received09/20/2017
10/24/2017
Supplement Dates FDA Received09/20/2017
11/22/2017
Date Device Manufactured06/15/2017
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;
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