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

Model Number 3116

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

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

Event Type  Injury  

Event Description

It was reported that the patient underwent surgery to replace the neurostimulator.It was noted that the device was removed and a lead fracture was noted and therefore the device was out of range.It was noted that the leads were cut and the device was removed.It was noted that there was some difficulty with the screws.It was noted that to resolve this issue the patient needed to be put asleep.It was noted that the patient was given local anesthesia for the procedure.It was noted that the patient¿s potassium was 7 and the surgeon was therefore unable to put her to sleep.It was noted that the patient would have to return for another surgery to replace the unit.It was noted that there was a malfunctioning gastric stimulator.It was noted that the reported event was ¿hospitalization.¿ it was noted that the patient recovered without sequela.It was noted that there were no complications and the patient tolerated the procedure well.It was noted that the patient would return for surgery at a later date.Additional information was requested but was not available as of the date of this report.

Manufacturer Narrative

Product id 435135, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2013(b)(6); product type lead product id 435135, serial# (b)(4), implanted: 2010 (b)(6), explanted: 2013 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type: lead.(b)(4).

Event Description

Additional information received reported that there was electrode dysfunction.It was noted that the patient had abdominal pain and nausea for the previous 3-4 months prior to replacement on (b)(6) 2013.It was noted that there were impedances on electrode 2 greater than 800 with normal on lead 3 normal 242 suggesting a poor connection with the generator.It was noted that the entire system was replaced on (b)(6) 2013.It was noted that the patient was in the office with an improvement in symptoms.

• 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: 3888742
• MDR Text Key: 4675829
• Report Number: 3004209178-2014-11924
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2014

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: 04/28/2011
• 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: 06/23/2014
• Initial Date FDA Received: 06/23/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/15/2014; 07/16/2014
• Date Device Manufactured: 11/10/2009
• 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; Required Intervention
• Patient Age: 00066 YR