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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Incontinence (1928); Inflammation (1932); Pain (1994); Hematuria (2558)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3058, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3093-33, lot# v839810, implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2006, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2006, product type: lead.

Event Description

Information was received from a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient recently had her neurostimulator battery replaced.The patient's hcp (healthcare provider) thought it was just normal battery depletion however the patient was wondering if it might have had something to do with a car accident she was in.She had both the battery and lead replaced however the patient didn't know why they replaced the lead.The patient had a car accident where the seat belt pulled really hard across her abdomen and she had a lot of pain in the area where the ins was but not a visible bruise.She went in for a scope and the hcp said there was a lot of inflammation of the bladder and kidneys and everything.That was why the patient had blood in her urine and difficulties "controlling".The hcp said it was just badly bruised, inflamed and it would go away.The patient reports it was also at this time that they realized the neurostimulator was turned off so they turned it back on again and it worked for some time before the battery died and needed to be replaced.Motor vehicle accident reported that could be related to this issue.This was consider a sudden change in therapy/symptoms.Event date for symptoms related to car accident was (b)(6) 2015.Ins battery depletion was in (b)(6) 2015.

Manufacturer Narrative

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

• 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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5519449
• MDR Text Key: 40945035
• Report Number: 3004209178-2016-05153
• 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,Followup
• Report Date: 02/23/2016

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: 05/14/2007
• 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: 02/23/2016
• Initial Date FDA Received: 03/23/2016
• Supplement Dates Manufacturer Received: 02/23/2016
• Supplement Dates FDA Received: 09/20/2017
• Date Device Manufactured: 11/15/2005
• 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: 00050 YR