MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 435135

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 37800, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id 435135, serial# (b)(4), implanted: (b)(6) 2005, product type: lead.(b)(4).

Event Description

The patient reported painful/shocking stimulation sensation.She feels it every day.Caller also mentions when the doctor did the replacement surgery he was "shocking the crap out of her" so bad she jumped off the table.The patient had no idea what may have caused this event.It's been like this since initial implant.The patient said the doctor said during implant surgery the leads were supposed to be at 600 but hers were running a little over 900 and he couldn't get it back down.Caller states doctor said maybe it punctured her.Caller states now its running 1800 and he can't get it to go down.The doctor keeps calling it the leads but she doesn't really understand what he was talking about.Caller states she had seen several hcps (healthcare providers) and had the manufacturer representative at the surgery when the device was replaced.The patient states he was made aware of the issue but nothing has helped.There was no troubleshooting during the call.The patient would like to see a different doctor because it appears her current doctor doesn't know how to get the leads to stop running so high.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.Additional information received from the representative reports he was not aware of any shocking issues at any time.He had no further information about this patient at this time.Additional information received from the healthcare provider reports the patient was having lead issues and was unable to be seen at requested facility.The patient will follow up with one of her previous doctor for evaluation.Additional information was being requested from the hcp regarding the shocking and lead issues.Follow up will be submitted if additional information is received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the health care provider (hcp) reported that the leads did not have high impedance.The action taken to resolve the impedance issue was that the hcp decreased the voltage.It was clarified that by puncturing her the hcp meant that the patient just felt some mild electrical activity.The patient did not receive shocking from all four implants since (b)(6) 2005 and the shocking was very temporary.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 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: 5327485
• MDR Text Key: 34964983
• Report Number: 3007566237-2015-04047
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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 Expiration Date: 06/09/2007
• Device Model Number: 435135
• Device Catalogue Number: 435135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Date Device Manufactured: 06/09/2005
• 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 Age: 00046 YR