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

Model Number 3116

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 03/02/2015

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient noted the device was bulging out and growing.It was noted that the implantable neurostimulator (ins) started bulging out of her abdomen around the 2nd week after implant.It started small about the size of a marble but had grown more and more and now looked like a golf ball.It was painful to do her daily activities.When she sits or lies down it doesn't hurt as badly but 5 weeks after surgery she felt she should be in pain and shouldn't have the device sticking out more and more.The patient noted you can see it through her clothes.They did xrays and the doctor said it looked fine but the patient stated when they did xrays she was lying down.Additional information received from the healthcare provider noted that there was a 50% or greater symptom reduction.It was noted that the patient did not expect to feel the generator under the skin.An x-ray was done and the patient was reassured.The event cause was determined; it was not device related.The patient was recovered without permanent impairment.Additional information was received from a consumer.It was reported that the device was moved to the other side due to the bulging.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient provided their weight at the time of the event.

• 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: 8791040
• MDR Text Key: 151054334
• Report Number: 3004209178-2019-13539
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Date Device Manufactured: 01/15/2015
• 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: 44 YR
• Patient Weight: 82