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

Model Number 37800

Device Problems Disconnection (1171); High impedance (1291); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: 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.

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that a patient's impedance was out of range.Upon further testing, the impedance was 3506 with c-3 lead at 3124 and c <(>&<)>2 was fine at 427.The patient stated they were receiving intermittent symptom relief.The rep stated that the hcp was sending the patient back to the implanting doctor for further evaluation.The patient stated that their 100lb dog jumped on them after they were recovering from surgery and that may have caused the issue.Follow up from the hcp noted there is a plan for surgery to replace/reconnect the lead and possibly the device.

Event Description

Additional information from the rep reported the patient was scheduled for a revision on (b)(6) 2017.

Event Description

Additional information from the healthcare provider (hcp) reported that the lead 3 was loose at the screws.The lead was removed, cleaned and reinserted and tightened with resulting impedance 512.The cause was noted to be that the loose lead 3 connection likely as a result of minor trauma (100lb dog jumped on the patient's abdomen).The hcp was unsure of the symptomatic changes at the time of the report.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6363918
• MDR Text Key: 68499903
• Report Number: 3004209178-2017-04709
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2017
• Date Device Manufactured: 05/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention