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

Model Number 8637

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

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

Event Date 04/02/2018

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 healthcare professional (hcp), via a manufacturer¿s representative (rep) regarding a drug infusion device.The drug being delivered was 500 mcg/ml baclofen (unknown) at 150 mcg/day.The reason for use was not reported.It was reported that the patient missed a refill.The rep received a call stating that the patient¿s refill date was supposed to be on (b)(6) 2018.An empty pump was reported and the caller did not have access to the patient or an 8840 clinician¿s programmer.¿the caller did not confirm an empty reservoir alarm, but based on the missed refill date and the programming they suspect the pump is empty.¿ empty pump considerations and catheter/tubing patency/damage considerations were reviewed.The caller asked about intrathecal to oral conversion and it was reviewed that there is no known conversion.The patient information and physician information was unknown.There were no symptoms reported.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep on (b)(6) 2018.It was reported that the doctor did a refill 2 days later, on (b)(6) 2018.The rep was unaware of the patient¿s name.The rep had no further information regarding the event.There were no further complications reported/anticipated.

• 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: 7437799
• MDR Text Key: 106204643
• Report Number: 3007566237-2018-01122
• 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: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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: 04/25/2018
• 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