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

Model Number 37800

Device Problems Break (1069); Migration or Expulsion of Device (1395); Low impedance (2285); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Nausea (1970); Twiddlers Syndrome (2114); Abdominal Distention (2601); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

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 that a patient's had impedance checked and the results of 2, 3 were less than 200ohms.The rep stated that at implant the impedance was 416ohms.Impedance were taken and the patient had c2 and c3 in the 300ohm range, but pair 2 and 3 were 100ohms.It was reviewed that the hcp would take xrays to see if the leads were touching.No further complications were reported/anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead, product id: 4351-35, (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the rep reported that the patient was experiencing nausea along with abdominal pain on their left side, and bloating.On (b)(6) 2017 impedance was measured and c-2 and c-3 were 327 ohms but 2-3 were 141 ohms.The rep stated they were going to check the impedances prior to the case, the following day, and have the physician cancel surgery if they were no longer less than 200 ohms.At the revision on (b)(6) 2017 the healthcare provider (hcp) concluded that the patient was flipping the implantable neurostimulator (ins).The lead were tangled and appeared damaged, and had pulled out of the stomach.The ins and the leads were replaced and the patient was "all set".No further complications were reported.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6510918
• MDR Text Key: 73382606
• Report Number: 3004209178-2017-08775
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2017

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: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 05/26/2017; 05/26/2017
• Supplement Dates FDA Received: 07/11/2017; 10/03/2017
• Date Device Manufactured: 06/15/2015
• 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
• Patient Age: 35 YR