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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Component Missing (2306); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Electric Shock (2554); Weight Changes (2607)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

It was reported that the device the patient got had missing parts.The patient¿s procedure had to be rescheduled.The patient¿s device did not seem to be doing its job.The patient was in constant pain and got shocked.She thought a lot of it had to do with where the device was implanted and it was placed on the right side instead of the left side because of her insulin pump.The patient was more nauseous than ever, her weight was still dropping, and she still wasn¿t able to eat.Before surgery the patient was able to eat and it would sit there, now she was lucky if she could get water without vomiting.Her symptoms started right after implant.The patient had discussed the issue with her healthcare provider.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 4351-35, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 4351-35, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 4152902
• MDR Text Key: 4910467
• Report Number: 3004209178-2014-18508
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

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: 09/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/08/2014
• Date Device Manufactured: 03/19/2014
• 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: 00047 YR