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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 22-jun-2007, udi#: (b)(4).(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a company representative regarding a patient receiving dilaudid 25mg/ml at ¿2mg/ml¿ and bupivacaine 25mg/ml at ¿2mg/ml¿ via an implantable pump.The indication for use was spinal pain.On (b)(6) 2018 it was reported that the patient had a ct scan that revealed that their catheter was not in the intrathecal space.There were no environmental, external or patient factors that may have led contributed to the issue and no diagnostics or troubleshooting was performed.The actions and interventions taken to resolve the issue was the catheter was replaced.The issue was resolved at the time of the report.The patient status at the time of the report was noted as alive, no injury and no further complications were reported or anticipated.

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: 7706815
• MDR Text Key: 114595024
• Report Number: 3004209178-2018-16265
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/28/2017
• 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 Outcome(s): Required Intervention