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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 Decrease in Pressure (1490); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Encephalopathy (1833); Fall (1848); Memory Loss/Impairment (1958); Overdose (1988); Dizziness (2194); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553); Lethargy (2560)
Event Date 07/20/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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 2000 mcg/ml unknown baclofen at a dose of 815. 7 mcg/day via an implantable pump for intractable spasticity and cva (stroke) das system. It was reported that for the last few months, the patient had been having serious problems including falls, extensive lethargy, rapidly deteriorating, cannot be present and alert without a lot of stimulation. The hcp felt that the symptoms may be related to baclofen overdose. The last six months the symptoms had been out of control including horrible memory, loses balance, cannot keep an entire sentence in place. These symptoms were considered a gradual change in therapy/symptoms. When the patient got up again she felt woozy, slow, and disoriented even though the settings were the same on the pump. The patient stated that she felt as if she was in slow motion and responded in slow motion. On her way to the doctor¿s office, the patient had a slow speed car crash at a four speed stop sign. The patient stated she was driving in a familiar street as if she was under water.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received from a healthcare provider (hcp) on (b)(6) 2017. When asked to clarify the baclofen overdose and patient symptoms, it was stated that the patient experienced and event of acute transitory encephalopathy of uncertain origin while vacating at an altitude of 9,000 feet. The symptoms resolved the following day. The pump was interrogated on (b)(6) 2016 and found to be functioning normally. At the refill on (b)(6) 2017, the expected volume of old drug was withdrawn. There were no actions or interventions performed. The hcp did not see evidence of baclofen overdose or overinfusion. The patient symptoms were resolved.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6271488
MDR Text Key100587659
Report Number3004209178-2017-01524
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2015
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 Received01/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2014
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: 01/23/2017 Patient Sequence Number: 1
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