MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Eructate (1839); Muscle Spasm(s) (1966); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported the patient was having weird muscle twitching on the left side of the abdomen and shocking sensations.It was noted this started on (b)(6) 2014 and the patient had pain in the area.The patient stated they had been relatively nausea free since the implant but they had been experiencing belching and nausea which started the morning of report.The patient indicated there was no known accident or incident related to the complaint.It was stated the patient did go shopping on (b)(6) 2014 and walked through the middle of the gates but they noted the symptoms were prior to going out shopping and they were getting worse.The patient was scheduled to meet with their doctor on (b)(6) 2014.Additional information from the healthcare provider stated the patient appeared to have incisional soreness only.It was noted there were no abnormal impedance measurements and no surgical intervention required.It was reported the patient had right-sided muscle spasm and their entire device including the battery was on the left.It was stated the patient had pain and tenderness over 8 mm from their site, reproducing their pain.It was noted this began with coughing from an upper respiratory infection.It was later reported the patient was still having concerns regarding their device or therapy but were working with their doctor or manufacturer representative.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3667333
• MDR Text Key: 21047440
• Report Number: 3004209178-2014-04088
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2014

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: 12/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/07/2014
• Date Device Manufactured: 06/27/2013
• 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 Age: 00032 YR