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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 8637-40
Device Problems Filling Problem (1233); Obstruction of Flow (2423); Protective Measures Problem (3015); Insufficient Information (3190)
Patient Problems Seizures (2063); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444); Shaking/Tremors (2515); Sleep Dysfunction (2517)
Event Date 09/06/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter. Product id: 85 96sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter. Product id: 8709, serial/lot #: (b)(4), ubd: 15-aug-2013, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 03-nov-2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2020-mar-06, information was received from a family member of a patient receiving baclofen (2,000 mcg/ml, 619. 1 mcg/day) via an implantable pump for intractable spasticity. It was reported the pump seemed to be working, but something was wrong. The caller reported the patient was tremoring once or twice in maybe the past 6 months or so, but she did not associate it with the pump. They were very slight and isolated occurrences, but last week, they became pronounced and ongoing. Last week, the patient had severe withdrawal. The caller initially thought the patient was having a seizure. The patient went to the emergency room (er). After a couple of nights of hospital stay, they thought the pump was working, but "suspect something [was] wrong in terms of connection". They did x-rays and the caller heard the healthcare professional (hcp) say something was blocking the catheter. The caller stated it was "something about catheter in the hub". They told her it was difficult to see the "connection" inside of the pump, it would not show on the x-ray. They "bolused' the catheter and caller thought the bolus actually unblocked whatever blockage the catheter was having. The patient seemed to be okay and went home, but after she came home, the patient still had been showing withdrawal symptoms (legs were jumpy, sweaty, shaking, tremoring). The caller stated, "this is week # 2 now". They were supplementing baclofen orally with a pill. The caller mentioned the pump was replaced in 2018, due to normal battery depletion but the catheter was not replaced, it was about 10 years old. The caller stated there was no alarm, but the patient has cerebral palsy and was non-verbal and could not tell if she heard any alarms. It was noted that when providing the drug information, the caller also read 25. 8 mcg/hour. The patient was on the same mediation as 6 months ago. The caller stated they have been grateful for the pump and it has been working beautiful until symptoms became ongoing last week.
 
Manufacturer Narrative
Product id: 8709, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter; product id: 85 96sc, serial# (b)(4), implanted: (b)(6) 2012. Product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer on 2020-jul-09. It was reported that the patient is in a wheelchair and have convulsion at night. The hcp has done several tests and he would like to know what the options are for the patient, maybe the pump/catheter will need to be removed. Caller states patient takes oral baclofen which helps patient symptoms. Technical (ts) and patient services (ps) conferenced with the caller and discussed pertinent information regarding options for discontinuing therapy and reviewed having this conversation with the managing physician. Ts reviewed pump/catheter functions. Ts/ps recommend caller consult with the hcp office and call ts if necessary, or consult with a local rep. There were no further complications reported/anticipated.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9806862
MDR Text Key196398384
Report Number3004209178-2020-04962
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/31/2018
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: 03/09/2020 Patient Sequence Number: 1
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