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

Model Number 3116

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the patient need to have his device taken out because he was ¿having a gastrectomy and the doctor might need to leave the ends of the lead wires in place.¿ the patient was concerned that this could affect his ability to have a mri.Three weeks later it was reported that the patient still had concerns regarding his device or therapy, but had sought further help.The patient wrote that he had numerous surgeries scheduled to remove his device.Additional information was requested, but was not available as of the date of this report.

Manufacturer Narrative

Concomitant products: product id 4351-35, serial # (b)(4), implanted: (b)(6) 2012, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2012, product type lead.(b)(4).

Manufacturer Narrative

Event Description

Additional information received reported that the cause of the event was that the patient had gastric bypass surgery.It was noted that no abnormal impedances measurements were known.It was reported that there was an explant and it was unknown if the patient required hospitalization.It was noted that the patient recovered without sequelae and the patient's healthcare provider hadn't seen them since surgery.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the cause of the event was no improvement in gastroparesis symptoms with the implantable neurostimulator (ins).It was noted that the explant had occurred and the gastric bypass was planned but not done yet.It was reported that signs and symptoms of the report event included all seven symptoms of gastroparesis.It was noted that the reporter thought the patient was limited in getting an mri he wanted with the ins in place.The patient outcome was noted as no injury.

• 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: 3579435
• MDR Text Key: 20356987
• Report Number: 3004209178-2014-00771
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2013

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: 12/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 01/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/13/2014; 02/14/2014
• Date Device Manufactured: 07/09/2012
• 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