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); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving morphine (unknown concentration or dose) via an implantable pump for spinal pain indications.It was reported that the patient had pain at the pump area.It was unknown when the pain started.Upon opening pump pocket on (b)(6) 2022, they found kinking and coiling of the catheter.Of note, they could not interrogate the pump pre-operation because the pump was flipped.The hcp cut off the old kinked and coiled catheter and replaced it with a new 8784 piece that was tunneled across the left abdomen of the new pocket site.They primed a new 8784 on the old pump before connecting to spinal segment because they did not get any csf backflow or aspiration from spinal portion. they checked the reservoir and aspirated more than expected sothey updated the reservoir volume in the tablet to the accurate volume.Same daily dose was kept on programming.Pump logs were checked and pump was ok with no motor stalls. pocket revision was done.There were no known factors that may have led or contributed to the issue. the issue was resolved at the time of report.The patient's weight and medical history were asked but unknown.The patient's status at the time of report was alive - no injury.

Manufacturer Narrative

Concomitant medical products: product id 8780 serial# (b)(4), implanted:(b)(6) 2021.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4) ubd: 20-aug-2022, udi#: (b)(4).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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13971182
• MDR Text Key: 288681548
• Report Number: 3004209178-2022-04100
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Date Device Manufactured: 07/09/2019
• 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
• Patient Age: 52 YR
• Patient Sex: Female