MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 435135

Device Problems Break (1069); High impedance (1291)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3116, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2015, product type: implantable neurostimulator.(b)(4).

Event Description

The health care provider (hcp) reported the patient had surgery to replace the depleted stimulator battery and repair 3 hernias.There was an umbilical hernia that was incisional and also two smaller defects cephalad to the umbilical defect.High impedances (over 800 ohms) were found and later a fractured lead during the operation.The lead was removed and replaced as a result which resolved the impedance issue.An endoscope was used to check placement.The patient tolerated the procedure well and was in good condition.Additional information received from the hcp reported the depletion was normal.The cause of the hernia and lead fracture was not determined.The patient's relevant medical history includes urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.See manufacturing report 3004209178-2015-25549.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5325054
• MDR Text Key: 34300597
• Report Number: 3007566237-2015-04030
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2015

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: 04/26/2013
• Device Model Number: 435135
• Device Catalogue Number: 435135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/23/2015
• Date Device Manufactured: 04/26/2011
• 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: 00061 YR