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

Model Number 3116

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

Patient Problem Hernia (2240)

Event Type  Injury  

Event Description

It was reported that a patient had a ventral hernia and had surgeries for the ventral hernias.It was noted that the patient was told that ventral hernias were one of the risks of having abdominal surgery and of having the device put in.It was reported that the patient¿s last hernia surgery was six months ago and she was going to have another one in a week.The reporter stated that it was a ¿central¿ hernia, the patient was told that she had very hard muscle tissue when they did the implant, and about a year later, she was aware of the ventral hernia.It was noted that the hernia got worse as the patient had a child.It was reported that the patient had a bio-mesh put in six months ago, the mesh was doing well, and she had not had any reactions.The patient had already had a ct scan.Additional information has been requested but was not available as of the date of this report.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: 2010 (b)(6); product type lead product id 435135, serial# (b)(4), implanted: 2010 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

Product event summary #reviewed and confirmed / updated rfr, hazard, and conclusion codes.A good faith effort for follow-up was completed.The ipg remains implanted.The event did not allege a potential manufacturing issue; therefore, a dhr review was not required for the ipg.The event was reviewed for existing investigations and none applied.The event was reviewed for known inherent risks listed in product labeling and none were noted.Reviewed for escalation to ncet and escalation was not required.The investigation of the ipg is inconclusive because the cause and outcome of the event were not determined.Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2010 product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the consumer on (b)(6) reported she had her device explanted because of hernias that were developing.The patient noted they had their device explanted however was in treatment from healthcare professionals (hcp).The patient noted she got her device removed because of ventral hernias she was getting.The patient noted she first started getting hernias back in 2012.The patient stated they did a couple of repairs however she was still getting them.The patient had everything explanted on (b)(6) 2018 and then to fix the hernias.There were no further complications that have been reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 3676881
• MDR Text Key: 4238193
• Report Number: 3004209178-2014-04378
• 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
• Report Date: 09/25/2018

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: 10/14/2011
• 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: 03/13/2014
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 09/25/2018
• Date Device Manufactured: 04/23/2010
• 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: 00028 YR