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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 Pumping Stopped (1503)
Patient Problems Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
Event Date 04/30/2020
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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal hydromorphone 7. 5 mg/ml at 3. 99 mg/day, bupivacaine 7. 5 mg/ml at 3. 99 mg/day, and baclofen 100 mcg/ml at 53 mcg/day via an implantable pump. It was reported that the patient heard a critical alarm. The patient experienced withdrawal symptoms (restless legs + restless in general). Motor stall showed on the screen of the tablet. Logs were read. No further diagnostics/troubleshooting were performed. The pump was replaced. The catheter was okay. The issue was resolved. The patient's status was alive - no injury. The pump would be returned to the device manufacturer. Information regarding the patient¿s age, weight, medical history, and other medications was unavailable. It was noted that the pump was implanted in (b)(6) 2014 (month and year valid).
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10039437
MDR Text Key190501852
Report Number3004209178-2020-08333
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 05/08/2020 Patient Sequence Number: 1
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