MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problems Device Operates Differently Than Expected (2913); Environmental Compatibility Problem (2929)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, product type: lead.Product id: neu_unknown_lead, product type: lead.(b)(4).

Event Description

The consumer reported that a patient's battery was damaged while scuba diving.No troubleshooting, interventions, or outcome were reported regarding this event.Additional information could not be obtained at the time of the report.Should additional information be received, a supplemental report will be filed.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5196276
• MDR Text Key: 30469730
• Report Number: 3007566237-2015-03177
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2015
• 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