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

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Obstruction/Occlusion (2422); Abdominal Cramps (2543)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.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.

Event Description

A patient reported they had painful stomach cramping since (b)(6) 2017.They were scheduled for an appointment with their healthcare provider on (b)(6) 2017 but really wanted to turn stimulation down or off as soon as possible.The rep was contacted and the hcp were contacted and they wanted the appointments to remain the same and could not see them earlier.The patient would follow up with their hcp.The implantable neurostimulator (ins) was indicated for gastrointestinal/pelvic floor.

Manufacturer Narrative

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.

Event Description

Additional information from the healthcare provider reported that they did a ct scan for the patient, in relation to the painful stomach cramping.The cause was noted to be a small bowel obstruction.The hcp noted that there were no actions or interventions were taken and the issue was resolved.

Event Description

Additional information from the hcp stated that they were not sure if the cramping and obstruction were related to the device as the patient had so many other underlying issues.The ins was removed on (b)(6) 2017 and they believed it would be returned.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6305942
• MDR Text Key: 66663960
• Report Number: 3004209178-2017-02676
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/17/2017
• Supplement Dates FDA Received: 02/10/2017; 03/15/2017; 09/29/2017
• Date Device Manufactured: 09/20/2016
• 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: 56 YR