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

Model Number 37800

Device Problems Break (1069); Degraded (1153); High impedance (1291)

Patient Problems Nausea (1970); Pain (1994); Paresis (1998)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Product id :4351-35, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had increased nausea and pain.The pain was located around their battery and shooting up towards their rib cage.The hcp found that c and 3 impedance was 1,500 [ohms].They were planning on removing the entire implant and replacing it on (b)(6) 2019.The issue was not resolved at the time of the report.No further complications were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id :4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient had been doing quite well until the end of (b)(6) 2018, when they noticed the increased pain in their left, upper quadrant of their posterior margin.They also had substantially increased difficulty with their oral intake and their symptoms of gastroparesis had increased.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that, when the hcp did the surgery and began removing the leads, it was like they were disintegrated when they pulled them away from the gastric wall.The leads broke into two with very little pressure.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the entire system was replaced.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the 1,500 impedances were caused by the leads, which appeared friable and fractured almost instantly.They noted this was both the lead and insulation.The impedances resolved after replacement.

• 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: 8292526
• MDR Text Key: 134586152
• Report Number: 3004209178-2019-02116
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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,Followup,Followup,Followup
• Report Date: 06/05/2019

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: 05/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 03/04/2019; 05/09/2019; 05/23/2019
• Supplement Dates FDA Received: 02/26/2019; 03/22/2019; 05/21/2019; 06/05/2019
• Date Device Manufactured: 12/13/2016
• 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
• Patient Age: 56 YR
• Patient Weight: 66