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

Model Number 3116

Device Problems Electro-Static Discharge (2149); Electromagnetic Compatibility Problem (2927)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Abdominal Distention (2601)

Event Type  malfunction  

Event Description

It was reported the patient did not have fifty percent symptom reduction.X-rays showed a stable position of leads.The patient had a gradual loss of therapeutic effect.

Event Description

It was reported that the patient had a loss of therapeutic effect.The patient had pain when bloated and when checking the lead impedance via the data management tab.The action required as a result of the event was an upper endoscopy and the action was not taken yet, but was planned.Diagnostic testing or troubleshooting of impedance testing and x-rays were performed.It was unknown if the product issue was resolved and unknown if the cause of the issue was determined.The patient also had less than 50 percent therapy relief and the patient status was alive with no injury.The patient also mentioned being struck by lightning and being close to radar while on a boat.It was later reported that there was no change and the patient¿s health care provider (hcp) was considering a revision and or replacement of the system.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2009, product type: lead.(b)(4).

Event Description

It was reported the patient had a greater than fifty percent reduction in symptoms.The patient had the endoscopy and there was no lead erosion.The patient had also experienced overstimulation and shocking.

Manufacturer Narrative

(b)(4).

• 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 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: 4195875
• MDR Text Key: 5079957
• Report Number: 3004209178-2014-20235
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Date Device Manufactured: 03/08/2013
• 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