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

Model Number 8637-40

Device Problems Filling Problem (1233); Suction Problem (2170)

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

Event Date 08/03/2018

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 provider (hcp) via a device manufacturer representative regarding a pre-implant pump.There was no patient involvement in the event.It was reported that the hcp got 32 mls of sterile water from new pump.The pump case was normal.The hcp tried to fill the pump to capacity and only got 39 mls in.They then tried aspirating out syringes full of air a few times and then was only able to get out 37 mls of the pfns.The event date was (b)(6) 2018.No further complication was reported.

Manufacturer Narrative

The pump was returned for analysis and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

The pump was returned with no new information.

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: 7756894
• MDR Text Key: 116897602
• Report Number: 3004209178-2018-17541
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• 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