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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead.Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient was seen in the clinical with abdominal pain and an endoscopy showed a protrusion of both electrodes into the lumen of their stomach through the mucosa at the junction of the gastric body and antrum.It was noted that there was a lead/extension/accessory dislodgement and positioning difficulty.Surgery for the removal of the system was scheduled and performed on (b)(6) 2017 and 2 partial leads were removed.The patient did not have any symptoms of gastroparesis, therefore a new system was not implanted during this surgery.The following parameter history was reported: initial setting 11.9, pulse width 330, rate 14, voltage 4v, impedance 331 ohms (noted to be normal while dislodged), and cycling single stim mode.1 second on time and 5.0 second off time.The patient recovered without sequelae.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis of the ins (b)(4) and leads (b)(4) and (b)(4) found insignificant anomalies; the ins was functionally okay and the leads had been cut through/segmented.The ins passed functional testing and there were no issues when pressing on the ins can.Telemetry was acceptable.The ins output was tested at the cut end of the returned lead.Good stable output was observed on all electrode pairs the ins had when it was received as well as on all pairs.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (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.

• 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: 7470717
• MDR Text Key: 106831140
• Report Number: 3004209178-2018-09542
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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: 10/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2015
• 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: 33 YR