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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 Fainting (1847); Low Blood Pressure/ Hypotension (1914); Pain (1994)
Event Date 08/30/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued. 4900240000-2018-8131.
 
Event Description
Information was received from a healthcare provider via a clinical study regarding a patient receiving hydromorphone and bupivacaine via an implanted pump. The indication for use was spinal pain. It was reported, on (b)(6) 2018 the patient had an episode in which when activating the personal therapy manager, ptm, the patient fainted 30 minutes late with a low blood pressure measuring at 45/15. The patient was transferred to the emergency department via ambulance and was instructed at the hospital to activate the ptm when pain increased and the same symptoms again occurred. The patient stopped activating the ptm, as per instruction from hospital physician until the hcp could have the dose adjusted. The symptoms ceased while not activating ptm. The patient presented to the clinic for adjustment and the bolus dose was decreased. The clinical diagnosis was it medication side effects following ptm activations. It was indicated the event was related to the device or therapy and related to the drugs hydromorphone and bupivacaine due to increased dose. The issue resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the patient was receiving hydromorphone (10 mg at 3. 60775 mg/day) and clonidine (500 mcg/ml at 180. 38755 mcg/day) via an implantable pump.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the cause of the fainting was the it medication when the ptm was activated. The patient's weight was (b)(6).
 
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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 Key7999914
MDR Text Key124836971
Report Number3004209178-2018-23781
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,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/14/2020
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 Received01/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/20/2018
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: 10/24/2018 Patient Sequence Number: 1
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