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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Encephalopathy (1833); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Muscular Rigidity (1968); Nausea (1970); Vomiting (2144); Weakness (2145); Malaise (2359); Loss of consciousness (2418); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553); Lethargy (2560)
Event Date 10/30/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving baclofen of unknown concentration at an unknown dose rate via an implantable pump for intractable spasticity. It was reported that the patient had a dose increase on (b)(6) 2018 and early morning yesterday ((b)(6) 2018) the patient came into the emergency room. The patient was now in the intensive care unit (icu) with altered mental status. A company representative was requested to come to the facility to assist with programming the pump. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a healthcare provider (hcp). The patient had a past medical history of multiple sclerosis, meningioma, s/p vp shunt, s/p urostomy/colostomy, hypothyroidism, prior deep vein thrombosis (dvt) / pulmonary hypertension and was admitted to a hospital (b)(6) 2018 due to pneumonia (suspected aspiration). The status of the patient was listed as ¿disabled¿. It was further reported that the patient was in-patient with altered mental status. The date of admission was (b)(6) 2018 and the date of discharge was (b)(6) 2018. It was also noted that the patent presented to the hospital on (b)(6) 2018 (this date is conflicting with the report of date of admission having been (b)(6) 2018) for evaluation of weakness, confusion, nausea with vomiting, and decreased responsiveness. Workup in the emergency department (ed) was fairly unremarkable; however, urinary analysis was consistent with a uti. Urine culture returned positive for klebsiella and enterobacter, both sensitive to rocephin. It was indicated that the patient had noted cloudy/foul smelling urine for three weeks. The patient was started on rocephin intravenously for five days. The patient was to transfer to oral omnicef to complete a total of seven days of therapy. The listed active hospital problems were as follows: nocturnal hypoxia (date noted: (b)(6) 2018), urinary tract infection (date noted: (b)(6) 2018), hypertension (date noted: (b)(6) 2018), history of pulmonary embolus (date noted: (b)(6) 2018), status post (s/p) ventriculoperitoneal (vp) shunt (date noted: (b)(6) 2018), weakness (date noted: (b)(6) 2018), and multiple sclerosis (date noted: (b)(6) 2015). A ct of their head on (b)(6) 2018 was unremarkable; xr series of the vp shunt was normal. Magnetic resonance imaging (mri) of the brain with and without contrast was performed on (b)(6) 2018; a past mri was noted as having been previously performed on (b)(6) 2013. It was further reported that the patient also noted that the rate of her baclofen pump was increased recently and since the change, she had been feeling not quite herself. On the evening of (b)(6) 2018, the patient had vomited, developed hypotension, and worsening mentation. The patient was transferred to the intensive care unit for closer monitoring. Neurology was consulted, and the physician felt the patient¿s confusion was most likely related to her infection or medication effect from baclofen pump increase. It was noted that the pump manufacturer was notified, and her pump was decreased from 575 to 400 mg. It was indicated that the patient would need to follow-up with the neurosurgery team for continued monitoring. It was indicated that the patient was concerned that their pump may have malfunctioned. It was indicated that the patient reported that she had follow-up arranged with her urologist on (b)(6) 2018 and was working to arrange for baclofen pump follow-up. Regarding the day of discharge, the following history of present illness (hpi) was listed as follows: patient was feeling much better, mental status had returned to baseline, no chest painor dyspnea, n/v/d (nausea/vomiting/diarrhea) or constipation was denied, and urostomy was functioning well. It was further indicated that the patient had no fevers, chills, palpitations, cough, or abdominal pain. A review of systems was negative except as mentioned in the hpi. The hospital problems that were resolved as of (b)(6) 2018 were listed as follows: sepsis (¿probably urinary source¿; date noted: (b)(6) 2018), encephalopathy acute (date noted: (b)(6) 2018), and aspiration pneumonia (¿possible¿; date noted: (b)(6) 2018).
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8039577
MDR Text Key126177438
Report Number3004209178-2018-24717
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,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/13/2016
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: 11/05/2018 Patient Sequence Number: 1
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