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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 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.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 04-aug-2017, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 04-aug-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 provider (hcp) regarding a patient with an implanted neurostimulator (ins) for gastroparesis.It was reported the patient experienced a migration of their leads and had a robotic lead revision and revision of the pocket along with an esophagogastroduodenoscopy and reprogramming.It was noted the patient had their gastric stimulator placed the year prior.They experienced a complete revision in their symptoms since the time of implant and had 2 back surgeries, since that time they had a recurrence of symptoms and their impedance had increased.A system revision occurred, it was noted that the stimulator was interrogated after placement and the impedance was found to be 459.The voltage was set to 2.0 and on time was changed to 1, off time to 4.The procedure was well tolerated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11200997
• MDR Text Key: 227744512
• Report Number: 3004209178-2021-01015
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• Date Device Manufactured: 12/23/2014
• 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