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

Model Number 3116

Device Problems Break (1069); High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

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) 2015, explanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: lead.

Event Description

The health care provider (hcp) reported that the patient had idiopathic gastroparesis with gastric stimulator placement, revision, and then failure.Recently the patient was having difficulties and the system was interrogated.It showed a resistance in the system of greater than 800 ohms, which suggested a break in the system.The hcp met with the patient and they elected to proceed with replacement.The patient had a gastric stimulator replacement including the leads on (b)(6) 2016.The resistance in the system was approximately 540 ohms after replacement and it was set to the nominal settings.The patient also had an upper gastrointestinal endoscopy.There were no complications and the patient tolerated the procedure well.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6096894
• MDR Text Key: 59716563
• Report Number: 3004209178-2016-23817
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Date Device Manufactured: 08/05/2014
• 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: 44 YR