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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Muscular Rigidity (1968); Nausea (1970); Scar Tissue (2060); Dizziness (2194)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc; lot#: n172906010; implanted: (b)(6) 2008; product typ: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), 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 (rep), healthcare provider (hcp)) regarding a patient who was receiving gablofen (2000 mcg/ml at 240 mcg/day) via an implantable pump for unknown indications for use. It was reported that the patient experienced itching, increase spasticity, dizziness and nausea 24 hours after pump was replaced on (b)(6) 2022. Oral baclofen and oral steroids did not alleviate the symptoms so the patient was admitted into the emergency room in (b)(6). Iv steroids were administered which took the edge off the itching and nitropaste was given for the patient's hypertension. There were no factors that may have led or contributed to the issue. The patient was transferred to (b)(6) emergency room via ambulance on (b)(6) 2022. They were able to withdraw csf (cerebrospinal fluid) from the cap (catheter access port) but only after manipulating the pump. The patient was given a 25 g bolus programmed for the pump and responded well. The patient was discharged on (b)(6) 2022 after increasing infusion rate from 184 g per day to 200 g per day. After the patient was back home in (b)(6), the local man aging physician increased the infusion rate again to 240 g per day. The patient again experienced itching and increase spasticity so they came back to (b)(6). A dye study was attempted on (b)(6) 2022 and they were unable to withdraw csf even with pump manipulation. Rotor study done with expected 60° of counterclockwise movement. Upon surgically opening the pump pocket site, the neurosurgeon stated that they did not see anything out of the ordinary. They accessed the catheter port with the 24 gauge noncore needle and easily withdrew csf. Upon disconnecting the existing catheter from the existing pump, spontaneous retrograde flow of csf was observed. They reconnected the existing catheter to the existing pump, and again was easily able to withdraw csf from cap. Interrogation of pump was 17. 9 ml expected residual volume in reservoir which matched 17. 9 ml actual residual volume. The medication was then injected back into the pump reservoir. The neurosurgeon stated that they suspected intermittent positional catheter kinking that may be caused by scar tissue that was in the pump pocket site and/or getting caught in one of the four suture loops. They subsequently evacuated scar tissue from the pump pocket site and cut two of the four suture loops that were in closest proximity to the catheter. The issue was resolved at the time of report. 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: 14149619
• MDR Text Key: 290465315
• Report Number: 3004209178-2022-04971
• 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
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 05/02/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/18/2022
• 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: 04/19/2022 Patient Sequence Number: 1