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 Abdominal Pain (1685); Nausea (1970); Urinary Retention (2119); Vomiting (2144); Discomfort (2330); Disability (2371)

Event Type  Injury  

Event Description

It was reported that the patient had severe nausea, extra abdominal pain, and vomiting.There were no diagnostic procedures, therapeutic actions, or surgeries reported.However, it was noted that a ct scan was performed which was unremarkable.The patient later had mild abdominal discomfort and felt like she was retaining urine.The patient reportedly was hospitalized for 5 nights and recovered from event with therapeutic action on (b)(6) 2001.However, it also stated that the event continued without therapeutic action.Permanent disability was noted.Final outcome and cause/type of disability was note reported; follow up was conducted to obtain these answers.If any additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 30576sc, serial# unknown, product type: screening device; 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: 4190798
• MDR Text Key: 4962375
• Report Number: 3007566237-2014-03063
• 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: 06/20/2001

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: 06/20/2001
• Initial Date FDA Received: 10/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2014
• 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; Disability