MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problems Adhesion(s) (1695); Erosion (1750); Fungus (1872); Unspecified Infection (1930); Internal Organ Perforation (1987); Paresis (1998); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 09/16/2004

Event Type  Injury  

Event Description

It was reported that the patient ¿had not a great deal of success¿ with the device and was admitted to the hospital due to exacerbation of symptoms of gastroparesis.An endoscopy and exploratory laparotomy were performed; it was discovered that one of the leads penetrated through the wall of the stomach.Surgery was performed to repair the lead where ¿there appeared to be a great deal more adhesions.¿ the lead reportedly had ¿yellow staining consistent with bile leak¿ and there was ¿abdominal contamination by gastric contents.¿ it was noted that laboratory analysis determined that the substance was candida (torulopsis) glabrata.The leads were not connected to the wall of the stomach and they were not connected ¿as it was set up originally in the operating room,¿ so they were both removed.It was noted that there was ¿clearly a gastrotomy where it went into the stomach.¿ due to the suspected infection of the pocket, the leads were not replaced at the time and the abdomen was ¿copiously irrigated with antibiotic containing solution.¿ it was noted that a bile film was left in the abdomen to help prevent adhesions.The patient reportedly was discharged from the hospital on (b)(6) 2004 and recovered.It was later clarified that the lead penetrated through the wall of the stomach and that there was erosion of previously placed lead into the stomach, but the lead had not perforated the abdominal wall and no major infection was involved in the pocket as suspected.It was noted that the patient wanted to have the leads replaced later on.Additional information was requested.

Manufacturer Narrative

Concomitant medical products: product id: 4351, serial# unknown, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4042041
• MDR Text Key: 4903219
• Report Number: 3007566237-2014-02402
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2004

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 Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 08/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• 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; Life Threatening; Required Intervention