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

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.

• 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 Key: 6879048
• MDR Text Key: 86754946
• Report Number: 3004209178-2017-19695
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• 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 Date: 12/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 10/24/2017
• Supplement Dates FDA Received: 09/20/2017; 11/22/2017
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention