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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problem Muscular Rigidity (1968)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter. Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 26-jan-2023, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 05-feb-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (500 mccg/ml at 100 mcg/day) via an implantable pump for intractable spasticity. It was reported that the patient had been experiencing more and more spasticity since the initial implant. There were no factors that may have led or contributed to the issue. Logs were read and cap (catheter access port) aspiration was attempted on (b)(6) 2022 by managing healthcare provider staff. Cap aspiration was unsuccessful. The hcp was asked to revise the catheter on (b)(6) 2022. Upon examination, the hcp noted no spontaneous flow from the catheter nor was the hcp able to aspirate the catheter through the cap intra-operation. As the hcp worked from the pump back to the spinal incision making several cuts of the catheter to see if there was any flow. Not until the hcp pulled the catheter back quite a bit was the hcp able to see some dripping of csf (cerebrospinal fluid). The hcp decided at that point to replace the entire catheter as well as replace the pump even though there was no allegation of anything malfunctioning with the pump. The issue was resolved at the time of report. The patient's medical history was asked and will not be made available. The patient's status at the time of report was alive - no injury.

• 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: 14465519
• MDR Text Key: 292348322
• Report Number: 3004209178-2022-06564
• 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
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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: 05/21/2022 Patient Sequence Number: 1