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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 Kinked (1339); Obstruction of Flow (2423)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. Product id: 8781, serial/lot #: (b)(4), ubd: 11-oct-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving hydromorphone 2. 0 mg/ml for a total dose of 0. 4563 mg/day and bupivacaine 30 mg/ml for a total dose of 6. 844 mg/day via an implantable pump for spinal pain. It was reported during a scheduled pump pocket revision on (b)(6) 2018, surgical observation indicated a catheter kink was observed. The catheter was freed from the scar tissue and reattached to the pump. Other surgical intervention included the catheter kink was manually released on (b)(6) 2018. The device diagnosis was catheter kink. The outcome of the event resolved without sequelae on (b)(6) 2018. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. No further complications were reported/anticipated.
 
Manufacturer Narrative
Additional review determined that the previously reported information (pump pocket revision) pertains to manufacturer's report # 3004209178-2018-01757 [pump slanted forward during refill]. Additional information regarding that event will be reported under that manufacturing number. This manufacturing report pertains to the following information: [catheter kink]. 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 catheter kink was not determined. The patient's baseline weight was (b)(6) lbs.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional via clinical study indicated the patient was receiving hydromorphone 2. 0mg/ml for a total dose of 0. 4563mg/day and bupivacaine 30mg/ml for a total dose of 6. 844mg/day. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7525907
MDR Text Key108640913
Report Number3004209178-2018-11254
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/02/2017
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: 05/18/2018 Patient Sequence Number: 1
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