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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 8637-20
Device Problems Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964); Protective Measures Problem (3015); Insufficient Information (3190)
Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 06/01/2020
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 consumer regarding a patient receiving dilaudid and clonidine via an implanted pump. The concentration and dose were unknown by the reporter but it had been the same for at least 6-10 months. On (b)(6) 2020 the patient¿s daughter reported that it was determined yesterday (b)(6) 2020 by the doctor that the patient¿s pump had stopped working in (b)(6) and now the hcp (healthcare professional) wanted to remove the pump due to this. The hcp also did a dye test yesterday and was unable to definitively locate the catheter. Per the reporter, the patient had been suffering horribly for the last 6 or 7 weeks and didn't know that it was due to the pump until the hcp informed her yesterday that the pump had stopped working. The patient¿s blood pressure was so high that she had a stroke. The reporter stated that if the pump stopped working and she was not getting the clonidine it would explain her blood pressure going up. She also stated that the patient had been having horrible symptoms and could have been going through withdrawal because the pump stopped working. No further complications have been reported as a result of this event.
 
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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 Key10431804
MDR Text Key203715722
Report Number3004209178-2020-14438
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 company representative,consum
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2016
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: 08/20/2020 Patient Sequence Number: 1
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