MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems High impedance (1291); Malposition of Device (2616)

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

Event Date 05/09/2017

Event Type  Injury  

Event Description

The manufacture representative reported that the patient¿s ins was replaced due to normal battery depletion on (b)(6) 2017 and upon interrogating the new ins, the physician noticed impedances were too high.The physician did complete an egd and it was found that the leads weren¿t in the lumen.On (b)(6) 2017 the leads were replaced and connected to the existing ins that was implanted the week before and again were seeing high impedances over 20,000 ohms.The patient¿s device was tested several times, cleaned and made sure the ins was in the pocket but nothing was working.It was noted that the leads were good and intact.The ins was replaced and the impedance values were around 450 ohms.No medical symptoms were reported.There were no further complications reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, serial# unknown, product type lead ; product id neu_unknown_lead, serial# unknown, product type lead.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.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 435135, serial (b)(4), product type: lead.Product id: 435135, serial (b)(4), product type: lead.Additional review indicates information previously reported in manufacturer's report (b)(4)-3007566237-2017-02493 pertains to this manufacturer's report.Any additional information received related to this issue will be reported under this report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).Further review of the event determined that there was no placement issue alleged with the leads.If information is provided in the future, a supplemental report will be issued.

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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6578294
• MDR Text Key: 75546270
• Report Number: 3007566237-2017-01945
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 05/09/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 07/14/2017; 07/14/2017
• Supplement Dates FDA Received: 06/01/2017; 06/09/2017; 06/29/2017; 07/14/2017; 09/21/2017
• 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: 37 YR
• Patient Weight: 68