MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ENTERRA; INTESTINAL STIMULATOR

Model Number 7425G

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

Patient Problems Chest Pain (1776); Tachycardia (2095); Toxicity (2333); Disability (2371); Increased Respiratory Rate (2486)

Event Date 03/26/2001

Event Type  Injury  

Event Description

It was reported that the patient had tachycardia, coumadin toxicity, and chest pain pleuritic in nature.There were no diagnostic procedures , surgeries, or therapeutic actions taken.Physical examination summary stated that the patient received fluids for hydration and morphine for tachycardia and tachypnea.It was noted that the patient was hospitalized for 3 nights.The event reportedly ended on (b)(6) 2001 as the patient recovered from event with therapeutic actions, but then stated the event was continuing with therapeutic actions.Permanent disability was noted.Final patient outcome was not reported.Follow up information is being conducted to obtain this information.If any additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 4301-35, serial# (b)(4), product type: lead; product id 4301-35, serial# (b)(4), product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• 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: 4186534
• MDR Text Key: 5101005
• Report Number: 6000032-2014-00245
• 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: 06/21/2001

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 Expiration Date: 02/28/2002
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2001
• Initial Date FDA Received: 10/20/2014
• Date Device Manufactured: 09/11/2000
• 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; Disability
• Patient Age: 00053 YR