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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Pain (1994); Paralysis (1997); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Test Result (2695)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter. (b)(4).
 
Event Description
On (b)(6) 2015, additional information was received from a physician via (b)(4), regarding a patient who was receiving baclofen (500 mcg/ml) at 84. 95 mcg/day via an implantable pump in simple continuous mode. It was noted that the pump settings had been examined on (b)(6) 2015 at 14:23, and had not been changed since (b)(6) 2015 at 15:14. On (b)(6) 2015 at 14:25, the pump was reprogrammed to deliver baclofen (2000 mcg/ml) at 115 mcg/day via simple continuous infusion, a daily dose increase of 35%. A bridge bolus of 0. 391 ml was programmed.
 
Event Description
It was reported that the patient experienced baclofen withdrawal. Lab work was done on (b)(6) 2015 which found that the patient had a urinary tract infection (uti). On (b)(6) 2015, an abdominal computed tomography (ct) scan found normal pump and catheter placement. On (b)(6) 2015, additional lab work was done which found that the patient had decreased hemoglobin levels and an increased cardiac index. The patient was reprogrammed to receive a 50 mcg bolus. Lab work was done on (b)(6) 2015 which found that the patient still had a urinary tract infection (uti). An echocardiogram (eeg) was done on (b)(6) 2015 which showed abnormal results consistent with mild, nonspecific/generalized cerebral dysfunction. No seizure or epileptiform discharges seen. Lab work done on (b)(6) 2015 found that the patient had an elevated platelet count. The etiology was listed as a worsening or exacerbation of a pre-existing condition. The event was possibly related to the device or therapy but unlikely related to the implant procedure. The signs and symptoms included increased spasticity, increased tone in bilateral lower extremities, occasional itching, full body paralysis, and swelling and pain in bilateral legs and heels of feet. The event resulted in in-patient or prolonged hospitalization. The event had resolved without sequela on (b)(6) 2015. A follow-up report will be submitted if more information becomes available.
 
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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 NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key4946256
MDR Text Key13969299
Report Number3004209178-2015-14177
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 Study,Health Professional,health professional,stu
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/03/2014
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: 07/28/2015 Patient Sequence Number: 1
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