MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED EL; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8627L18

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Coma (2417)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving therapy via an implantable infusion pump.It was reported that probably 8 years ago the pump went haywire after a refill and dumped medication into the body.The patient ended up in a coma for 24 hours.The caller stated they did a pump study and they could not figure out what happened.The device was filled with saline.

• Brand Name: SYNCHROMED EL
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12599313
• MDR Text Key: 275445787
• Report Number: 2182207-2021-01757
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2005
• Device Model Number: 8627L18
• Device Catalogue Number: 8627L18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• 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