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

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Nausea (1970); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient was complaint that she had intermittent swelling in her abdomen along with bumps on their skin.It was noted when she swelled the implant hurt.The hcp explain that her issues had nothing to do with her implant, but she wanted it out.The hcp turned the implant off on (b)(6) and may explant her in a month.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.It was unknown if there were any diagnostics or troubleshooting performed.It was noted the issue was not resolved at the time of the report.The rep noted no surgical intervention occurred and it was unknown if it was planned.The patient was listed as alive with no injury at the time of the report.Additional information from the healthcare professional (hcp) reported on (b)(6) 2019 the device was turned off and the patient was scheduled for an explant of the implant on (b)(6) 2019.The hcp noted the patient had gained 54 lbs since they saw her last on (b)(6) 2017.The hcp stated on (b)(6) 2019 since her last visit the patient had a gastric pacer placed, she was at the hcp office on (b)(6) requesting explant of the gastric pacer.The patient stated that it did not work and made them worse.The patient described persistent nausea and inability to eat, despite that she had gained 50 pounds since the hcp saw her last, the patient stated it was mostly swelling, she was also unsure as to why diuretics had not helped with the swelling.The patient noted she had persistent abdominal pain and noted the pacer generator was particularly painful when her swelling was more pronounced.The patient did not recall that she had a seroma at the generator site and stated that the seroma eventually migrated into her lower abdomen.The patient denied abscess or infection at the site and stated the incision healed.It was noted the patient had a medical history of indigestion, diarrhea, excessive gas, and stomach pain.The patient denied any past hospitalization.It was noted the patient¿s gastrointestinal was soft, minimal tenderness, non-distended no hepatomegaly, and no splenomegaly.It was noted the patient¿s gastroparesis was 1 hour: 11% 2 hours: 30% 3 hours: 40% and 4 hours: 61%.The patient stated the pacer was not helpful and she believed it had made matters worse, and also stated that it was often painful.It was noted the hcp discussed just turned off the gastric pacer, she had agreed to turn it off, but would still like to move forward with surgical explant of the entire device.Additional information from the manufacture representative (rep) reported the hcp removed both leads and battery on (b)(6).There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Analysis results were not available at the time of this report.An additional report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the ins (b)(4) found that the ins was functionally okay and had insignificant anomalies.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: 8418244
• MDR Text Key: 138714680
• Report Number: 3004209178-2019-05214
• 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
• Report Date: 06/26/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 06/07/2019
• Supplement Dates FDA Received: 04/19/2019; 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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 Weight: 97