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

Model Number 8637

Device Problems Electromagnetic Interference (1194); Inappropriate or Unexpected Reset (2959); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a foreign healthcare provider (hcp) regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use.The hcp called technical services about a motor stall after mri.Technical services talked the hcp through steps on checking for recovery.Later, the hcp called back stating the pump was in safe state and they were unable to program the pump back to simple continuous mode.The hcp could see multiple low battery resets in the logs.The pump had been implanted for over six years.There were no reported symptoms.No complications were reported.

Manufacturer Narrative

Review of additional information revealed the information contained in this report has been previously reported in regulatory report 3004209178-2017-24719.All further information regarding this event will be reported under that reference number.If information is provided in the future, a supplemental report will be issued.

Event Description

Review of additional information revealed the information contained in this report has been previously reported in regulatory report 3004209178-2017-24719.All further information regarding this event will be reported under that reference number.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7064013
• MDR Text Key: 93244523
• Report Number: 3007566237-2017-04972
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0592-2009
• Patient Sequence Number: 1