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 Edema (1820); Paresis (1998); Swelling (2091); Thrombosis (2100); Discomfort (2330); Disability (2371)

Event Type  Injury  

Event Description

It was reported that the patient had right and upper extremity swelling/edema and discomfort after recent discharge from hospital.The diagnosis was listed as gastroparesis and upper extremity deep vein thrombosis.An upper extremity ¿doppler¿ showed stable old right distal vein thrombosis.The patient¿s swelling and edema went down gradually during her stay.It was noted that the patient was hospitalized for 7 nights and discharged home on lovenox and coumadin.It was stated that the event ended (b)(6) 2001 as the patient recovered from event with therapeutic action.However, it was also stated that the event continued with therapeutic action as well.Permanent disability was noted.Final outcome was not reported as well as more information on permanent disability; follow up is being conducted to obtain this information.A supplemental reportwill be sent if any additional information is reported.

Manufacturer Narrative

(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: 4189414
• MDR Text Key: 20979102
• Report Number: 6000032-2014-00247
• 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

• Date FDA Received: 10/21/2014
• 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
• Date Manufacturer Received: 06/21/2001
• 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: 00052 YR