MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN ENTERRA NEUROSTIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

It was reported the patient¿s ¿stomach pacemaker¿ had helped with amazing changes however, the patient almost died in (b)(6) 2013 and the surgeon who did the emergency surgery had to take the ¿pacemaker¿ out.It was noted that the wires were still going in the incision and hooked up.The patient had an open wound that the reporter stated they would forever have.It was reported that they taped the ¿pacemaker¿ to the patient and changed the bandage every few days.The reporter was terrified when they saw it earlier when changing it because of how much the patient¿s nurse had yanked on the wires.It was double coated about an inch out of the patient¿s stomach where the wires were going in.The patient¿s daughter was scared the nurse had pulled it out or something serious and dangerous.No additional interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

• Brand Name: UNKNOWN ENTERRA NEUROSTIMULATOR
• 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: 4189445
• MDR Text Key: 15116915
• Report Number: 3007566237-2014-03053
• 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: 09/04/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 10/21/2014
• 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): Life Threatening; Required Intervention