MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 435135

Device Problems Break (1069); Low impedance (2285); Impedance Problem (2950)

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

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The healthcare provider (hcp) reported via the manufacturer representative (rep) that a lead was fractured.The patient had gone int o the clinic for a follow-up visit and the device showed out of range.The patient had been feeling great.A secondary lead check was performed that showed lead 3 was less than 4000 ohms, signifying a potential break in the circuit for lead 3.A kidney, ureter, and bladder (kub) x-ray was done and the issue was noted to be resolved.The hcp had decided to replace the lead at the time of the next battery change and the patient confirmed wanting to wait until the battery depleted.The patient was alive with no injury.No surgical intervention had taken place but one had been planned.It had not been scheduled yet.Relevant medical history included gastric stimulation and gastrointestinal/pelvic floor.No follow-up was required.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The health care provider (hcp) via a manufacturer representative reported that the physician's assistance (pa) interrogated the patient's device and it showed out of range impedances.They conducted a secondary lead check and identified that lead 2 was the issue.No environmental, external, or patient factors contributed to the issue.The hcp brought the patient back to the operating room on (b)(6) 2016 to do a lead revision.The surgeon determined it was best to replace the entire system.The leads and implantable neurostimulator (ins) would be returned.The issue was resolved and the patient was alive with no injury.

Event Description

Additional information received from the manufacturer representative reported that they didn't have the device to send in.

• 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: 5445021
• MDR Text Key: 38486970
• Report Number: 3007566237-2016-00864
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2016

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: 12/10/2013
• 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: 01/26/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/18/2016; 05/02/2016; 06/10/2016
• Date Device Manufactured: 12/10/2011
• 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: 00024 YR