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

Model Number 37800

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problems Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Type  Injury  

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).

Event Description

The manufacture representative reported that the implantable neurostimulator (ins) intermittently turned off.The patient had a return of symptoms, namely nausea and vomiting, and discovered that the device was off.It was noted that this occurred twice.The first occurrence was in (b)(6) 2015 where the representative requested that the device be turned back on.Multiple event dates were listed for the second occurrence, such as (b)(6) 2015, so specific date was unclear.The patient reportedly wanted the device to be replaced.On (b)(6) 2015, the representative reported device was checked and determined to still be on so an exchange was not planned.The patient had been seen two additional times while in the hospital to confirm the device was on and was discharged on (b)(6) 2015 after confirming the device was on.On (b)(6) 2015, the representative reported that the patient had no means to turn the device on or off, so it was believed that it was some type of electromagnetic interference.The patient was currently being monitored and was scheduled for another check-up the following week.If the device was off at the next meeting, the device was to be replaced and returned for analysis.The device was implanted for gastric stimulation.Cause, actions, and patient outcome remain unknown.Follow-up is being conducted to determine additional information.

Event Description

Additional information received via the manufacturer representative reported that they were contacted by the patient's health care provider's (hcp's) office on (b)(6) 2015.They told him that the device was off and they were unsure why it was off and could not confirm it had been on or not prior to the paitent coming in.There were no patient symptoms reported to him at the time.The manufacturer representative advised the hcp to ask the patient if they had any emi exposure.The indications for use was gastric stimulation.

Manufacturer Narrative

Upon new information from the manufacture representative, it was determined that the date of the medwatch should have been 7-aug-2015, therefore medwatch is not late.

Event Description

Additional information from the manufacturers's representative noted the patient was doing well and her device remained on.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the representative reports the lead and stimulator were explanted on (b)(6) 2015.Device was returned and was not replaced with a manufacturer product.The patient felt they did not get relief.The patient was alive at time of report.

Manufacturer Narrative

Device evaluation concluded the stim ins ((b)(4)) functionally okay with insignificant anomalies.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 5002112
• MDR Text Key: 22943057
• Report Number: 3004209178-2015-16015
• 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: Followup,Followup,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2014
• 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: 00051 YR