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

Model Number 37800

Device Problems High impedance (1291); Electromagnetic Compatibility Problem (2927)

Patient Problems Purulent Discharge (1812); No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.(b)(4).

Event Description

A manufacturer representative reported during an implantable neurostimulator (ins) replacement procedure electrode impedances were r un; c <(>&<)>2 was 14,855 ohms, c <(>&<)> 3 was 12,000 ohms, and 2 <(>&<)> 3 was greater than 20,000 ohms.The last time impedances were run was before the patient's change out in 2013 and impedances on c <(>&<)> 2, c <(>&<)> 3, and 2 <(>&<)> 3 were greater than 800 ohms.The patient was doing fine with symptoms and everything was working fine until the battery went dead two months ago.The high impedance was caused by the patient's previously placed leads being left in the stomach wall.Indication for use was reported as gastric stimulation.If additional information is received, a follow-up report will be sent.Refer to mfr report # 6000032-2015-00178 for report regarding patient铠leads being cut and left in her stomach wall.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the health care provider (hcp) reported the patient was experiencing some increase in her nausea but not vomiting since battery change.The impedance readings were still way out of range.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the health care provider (hcp) reported the patient was experiencing some increase in her nausea but not vomiting since battery change.The impedance readings were still way out of range.

Event Description

Additional information from the health care professional reported that the patient showed up on (b)(6) 2016 with severe pain around her pocket.The device was turned off at that time with no change in the patient's symptoms.Apparently, about 2 months after the patient's last battery change, she presented to the office with slight increase in her epigastric pain.Her programming was increased at that time.The patient mentioned that at the time of her battery change, there was a lot of fluid in her pocket but the cultures were negative.Ct scan was negative.They were planning on removing the patient's battery and possibly the partial leads in the pocket on monday.They thought it might be infected.

Event Description

Additional information received from the manufacturer representative reported that the battery was removed in (b)(6) 2016 and they planned on removing their leads sometime in may as well as replacing with new leads and a new battery.

Event Description

Additional information received from the health care provider (hcp) via a manufacturer representative reported that the patient had surgery on (b)(6) 2016 to replace their leads and implant a new battery.The patient¿s leads actually had pus around them in the pocket where they were buried in the abdomen, so they were unable to replace the stimulator.They removed all the old wires and did a ¿toupe fund implication¿ and would follow-up in 6 to 8 weeks for replacement.

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

Additional information received from the manufacturer representative reported that the patient was implanted with new leads and a new battery on (b)(6) 2016.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5128710
• MDR Text Key: 27812073
• Report Number: 3004209178-2015-20034
• Device Sequence Number: 1
• Product Code: LNQ
• 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: Followup,Followup,Followup,Followup,Followup
• Report Date: 08/22/2016

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: 01/14/2017
• 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: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2016; 03/08/2016; 03/08/2016; 05/16/2016; 06/27/2016; 08/22/2016
• Date Device Manufactured: 07/15/2015
• 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: 00058 YR