MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Defective Device (2588); Connection Problem (2900); Insufficient Information (3190)

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

Event Date 06/20/2018

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 foreign healthcare professional (hcp) via a manufacturer representative regarding an implantable pump.Prior to use, they were not able to connect to the pump and it was stated "it comes up failure." the pump was called "defect." the pump was not implanted and would be returned.There was no patient involved in the event (therefore no patient complications were reported).

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative indicated it was unknown if a specific error message was received.Two different clinician programmers were used with the same result.It was unknown if there were any sources of electromagnetic interference (emi).No further information was available at this time.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative (confirmed via healthcare provider) indicated no specific error message was seen.The pump did not connect.The device information of the clinician programmers and application cards used were unknown.Sources of electromagnetic interference (emi) were not ruled out as interrogation was successful once outside of the operating room.It was indicated the pump would not be returned at this time.No further information was provided.

Manufacturer Narrative

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

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7679386
• MDR Text Key: 114143926
• Report Number: 3004209178-2018-15542
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 08/31/2018; 08/08/2018
• Supplement Dates FDA Received: 07/23/2018; 08/31/2018; 10/04/2018
• Date Device Manufactured: 01/30/2018
• 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