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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Vibration (1674)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported the patient never had therapeutic effect.The patient felt sick.Two weeks later, the patient still had concerns regarding their device or therapy, but was working with their healthcare provider or manufacturer representative.An appointment date of (b)(6) 2015 was noted.It was reported the patient¿s pocket started contracting and vibrating three days after increasing stimulation.It was reported that the patient¿s healthcare provider did not find anything wrong.Stimulation was adjusted from 5.0 v to 4.0 v.That helped for a day and then the stomach muscle contractions and shocking resumed.There were no falls, trauma, or activities associated with the issue.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

Additional information received reported that the patient continued to work with her health care provider (hcp) regarding her issue of shocking and vibrating and was told that it was finally determined that her device needed to be replaced.The patient's hcp and the manufacturer representative viewed videos of how the stimulation was vibrated in her abdomen.A replacement surgery was scheduled for (b)(6) 2015.The patient did not want to pay for any expenses related to the replacement surgery.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the consumer reported that the only the implantable neurostimulator (ins) was replaced.However, issue still had not resolved so the hcp reportedly believed that the leads should be replaced.No intervention was scheduled for the leads as of the report.

Event Description

Additional information received reported that the patient had the implant replaced on (b)(6) 2015.

• 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 1200
• 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: 4772721
• MDR Text Key: 5786249
• Report Number: 3007566237-2015-01318
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2015

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 Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 07/01/2015
• 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 Age: 00023 YR