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 Problems Fall (1848); Loss of consciousness (2418)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant: product id neu_unknown_lead, product type lead, product id neu_unknown_lead, product type lead.(b)(4).

Event Description

A healthcare provider (hcp) for a clinical study via a manufacturer representative reported on (b)(6) 2015, there was a rapid response called for unresponsiveness; the patient was found to have slid herself on the floor without trauma to her body or head.She was placed on a stretcher and was unable to be aroused with painful stimuli.The patient appeared to be actively preventing hcps from opening her eyes and she would not follow any command.Glucose at the time was 213 and all her vitals were stable.An ekg (electrocardiogram) revealed new t-wave inversions in leads v1, v2, and v5.The patient was transferred to tele for cardiac monitoring.Stat labs were sent including abg (aterial blood gases) which were nondiagnostic.History and review of symptoms were unable to be obtained at this time as the patient was in a catatonic state.On the floor the patient was clinically stable.Workup for fall/responsiveness was negative.The patient had an eeg (electroencephalogram) done that showed no epileptic activity and was unremarkable.The patient was not complaining of chest pain.An exercise ecg (electrocardiogram) was performed which was normal.A cxr (chest x-ray) was performed to rule out trauma.The patient had no complaints on the floor.She was placed on constant observation from admission to discharge.On day of discharge the patient was medically cleared for continued psychiatric care and she was discharged to behavioral health on (b)(6).Indication for use is drug refractory gastroparesis of idiopathic or diabetic origin.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, lot# nht024545n, product type: lead.Product id: 4351-35, lot# nht024543n, product type: lead.(b)(4).The initial mdr was filed as mfr report # 3007566237-2015-02526.Additional review indicated the correct manufacturing site is: (b)(4).

Event Description

Additional information received from a healthcare provider (hcp) for a clinical study, via a manufacturer representative, reported the patient was discharged on (b)(6) 2015.The event was determined to not be related to the device, therapy, or procedure in any way.

• 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: 5061958
• MDR Text Key: 25210808
• Report Number: 3007566237-2015-02526
• 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: 08/12/2015

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: 09/08/2015
• 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): Other