MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN TEMPORARY GASTRIC STIMULATOR; INTESTINAL STIMULATOR

Model Number 3625

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Nausea (1970); Pneumonia (2011); Pneumothorax (2012); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Test Result (2695)

Event Type  Injury  

Event Description

It was reported that the patient had a fever with probably line (central line) infection.An esophagogastroduodenoscopy (egd), acute abdominal series, pathology report stomach biopsies, and x-rays for triple lumen placement.The patient was hospitalized for 7 nights and recovered with therapeutic action on (b)(6) 2001.However, it was also stated that the event continued with therapeutic action.The healthcare provider¿s impression was ¿probable¿ minimal left basilar atelectasis, less likely early pneumonia and extensive post-surgical changes with gastrostomy tube in place.It was noted that the patient had a fever of 102 degrees ¿or so with some anterior chest wall discomfort.¿ the patient reportedly had ¿some¿ nausea, vomiting, and gastroparetic symptoms, as well as tenderness over lower thoracic spine and multiple bruises.Laboratory data was unremarkable except blood cultures showed growing gram (b)(6) cocci in clusters.An egd was performed as the patient had a percutaneous endoscopic gastrostomy (peg) placed for her gastroparesis and developed (b)(6).The patient reportedly started on empiric vancomycin.It was suspected that the peg had been infected.The final diagnosis was bile reflux, chronic superficial gastritis, and peg was in good condition.It was later reported that the patient ¿just had¿ an infected port removed from vein and both innominate veins were occluded.A left internal triple-lumen catheter placement was performed.Permanent disability was noted.Follow up was conducted.If any additional information is received, a supplemental will be reported.

Manufacturer Narrative

Concomitant medical products: product id: 30576sc, serial# unknown, product type: screening device.(b)(4).

• Brand Name: UNKNOWN TEMPORARY GASTRIC STIMULATOR
• 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: 4192509
• MDR Text Key: 5157600
• Report Number: 3007566237-2014-03068
• 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
• Report Date: 06/19/2001

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?: No
• Device Operator: Health Professional
• Device Model Number: 3625
• Device Catalogue Number: 3625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2001
• Initial Date FDA Received: 10/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability