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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key14149619
MDR Text Key290465315
Report Number3004209178-2022-04971
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
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 Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/18/2022
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
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