MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Malposition of Device (2616)

Patient Problems Anemia (1706); Death (1802); Edema (1820); Fatigue (1849); Hematoma (1884); Nausea (1970); Pain (1994); Seroma (2069); Discomfort (2330); Complaint, Ill-Defined (2331); Impaired Healing (2378); Irritability (2421); Cognitive Changes (2551); Ascites (2596); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191)

Event Type  Death  

Event Description

It was reported that the device hurt the patient's ribs and that her wound was healing "abnormally." the patient was reportedly "agitated," concerned about her device and its position, and concerned about the hardness of her incision which was "pulling up on her tissues." physical examination of the wound found that the wound appeared well healed and not overly hard while the pocket was "somewhat protuberant" and "may have been filled with fluid.¿ it was not clear if it was an infection.The healthcare provider (hcp) "wondered if it reflected the ascites" that he found during implantation, which he felt was "nutritional refeeding edema." the patient¿s review of systems is positive for fatigue, weight loss, abdominal pain, nausea, water retention, but otherwise negative.Problems included severe gastrointestinal problem, psychological issues, chronic abdominal pain, atrial thrombus and deep venous thrombosis, and anemia of chronic disease.Both the patient and hcp stated that the device was closer to the right rib cage than expected.Pain could be due to the distention of pocket; aspiration of the pocket would relieve some of the patient's discomfort.An ultrasound was performed and showed that the distension was most likely due to a resolving hematoma.The healthcare providers (hcp) reportedly ¿did the very best¿ for the patient and it was ¿up to her to get things working right.¿ a jejunostomy tube was placed to supplement oral intake, but the patient stated it was too painful to continue the infusion of calories.Therefore, oral intake was all that was left to maintain nutrition.However, the patient reportedly decreased oral intake due to abdominal pain.The patient reportedly ¿wasn¿t willing to help herself¿ and ¿didn¿t want to save herself,¿ and had expired on (b)(6) 2003.At the time of death, the patient weighed just (b)(6).The patient¿s family member stated that ¿no one was willing to admit¿ that the patient was ¿anorexic, but just by looking you could tell.¿ additional follow-up is being conducted to obtain this information.A supplemental report will be sent if any additional information is received.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: same event reported in manufacturer report # 3007566237-2011-05621.Files being merged.However, report is not being redacted as this report still contained information that was not previously reported in report # 3007566237-2011-05621.Any additional information received will be updated in supplemental reports of 3007566237-2011-05621.

• 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: 4194321
• MDR Text Key: 4979847
• Report Number: 3007566237-2014-03082
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 700724871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2003

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: 12/19/2014
• Initial Date FDA Received: 10/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• 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): Death