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

Model Number 3116

Device Problem Failure to Deliver Energy (1211)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that there was a sudden onset of return of symptoms.The sudden onset of symptoms occurred between (b)(6) of 2014.The last time the patient felt stimulation was at that timeframe as well.The patient had an appointment scheduled for the following friday, indicating a replacement surgery.Patient outcome and specific symptoms were not given.Follow-up is being conducted to obtain this information.

Manufacturer Narrative

Concomitant products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was later reported that the healthcare provider was unable to find the implantable neurostimulator (ins) battery and said that the ins battery was dead.It was noted that the healthcare provider checked the ins "a couple of fridays ago." the patient's symptom return started the summer prior to report.The patient did not know if it was normal end of life.

• 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: 4519457
• MDR Text Key: 5406141
• Report Number: 3004209178-2015-03072
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2011
• 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: 02/17/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2015
• Date Device Manufactured: 07/01/2010
• 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: 00050 YR