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

Model Number 8637-40

Device Problem Difficult to Advance (2920)

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

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 01-oct-2021, udi#: (b)(4).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 company representative regarding a patient going to be receiving dilaudid (5 mg/ml at 500 mcg/day) via an implanted pump.During the initial device implant procedure on (b)(6) 2020, the physician could not get the catheter advanced past the needle tip.He pulled the needle out and the catheter did advance.He then attempted catheter advancement using the same needle, but the catheter would not advance.A new catheter was opened and that one also did not advance.He then tried a new needle and the catheter advanced easily.The pump was then implanted without issue.There were no environment factors that may have caused or contributed to the issue.The patient had no symptoms.The event occurred intra-operatively.The issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event.The patient status was reported as ¿alive ¿ no injury¿.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter.Visual inspection identified damage/foreign material in the introducer needle.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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9989708
• MDR Text Key: 188676142
• Report Number: 3004209178-2020-07563
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: 06/10/2020

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: 06/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 06/08/2020; 06/10/2020
• Supplement Dates FDA Received: 06/09/2020; 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2020
• 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 Age: 65 YR
• Patient Weight: 105