MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cognitive Changes (2551)

Event Date 07/21/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

Event Description

The healthcare professional (hcp) of a clinical study reported that the patient was admitted to the hospital on (b)(6) 2015 for a suicide attempt.The patient was admitted to a medical floor and then discharged to the behavioral floor.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).The initial mdr was filed as mfr report # 3007566237-2015-02335.Additional review indicated the correct manufacturing site is 3004209178.Medical safety assessed the event as not related to the device or therapy but is instead related to pre-existing patient diagnosis, including depression.Patient code c50457 no longer applies to this event.

Event Description

Additional information from the health care professional of the clinical study reported when the patient was in the emergency room for another medical reason the patient attempted to commit suicide.The patient remained medically stable and they were transferred to psychiatry once medically optimized.The patient was transferred during admission for gastric pacer but it was unclear what was meant by this.As of (b)(6) 2015 the patient was still hospitalized on the behavioral medicine floor.The patient had a history of depression and the event was noted to be unique to this patient.The event was still ongoing; if outcome is received a follow-up report will be sent.Indication for use is drug refractory gastroparesis of idiopathic or diabetic origin.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 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: 5019242
• MDR Text Key: 23654816
• Report Number: 3007566237-2015-02335
• 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: Physician
• Report Date: 07/23/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Date Device Manufactured: 06/01/2015
• 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): Hospitalization
• Patient Age: 00033 YR