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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2022, product type: catheter; product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2009 , explanted: (b)(6) 2022 product type: catheter ; other relevant device(s) are: product id: 8731sc, serial/lot #: (b)(4), ubd: 05-jun-2009, udi#: (b)(4); product id: 8598a, serial/lot #: (b)(4), ubd: 17-sep-2009, udi#: (b)(4). 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 company representative regarding a patient receiving prialt/ziconotide via an implanted pump. It was reported that the pump pocket was filling with fluid that required draining every few days. The hcp believed the seroma may be related to the catheter. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The hcp performed a dye study on (b)(6) 2022 and the dye study was inconclusive. A catheter replacement was planned for (b)(6) 2022. The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13928179
• MDR Text Key: 288026583
• Report Number: 3004209178-2022-03828
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/28/2022 Patient Sequence Number: 1