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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Pneumonia (2011); Cognitive Changes (2551); Confusion/ Disorientation (2553); No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2018
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 who was receiving dilaudid, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain. It was reported that patient went to the hospital for confusion the day after implant (b)(6) 2018. Patient was in the hospital for 13 days until the (b)(6) 2018 then he got pneumonia and then went to nursing center for rehab. Patient had been hallucinating and confused- talking to people that were not there since (b)(6) 2018. Patient was highly allergic to morphine. The healthcare professional office did confirm it was dilaudid in the pump. The manufacturer representative came in and turned the pump to the lowest dose- (b)(6) 2018 (after about the third day he was in the hospital). The patient was on oxycodone and it suppressed his breathing- they had to put him on a ventilator and then they turned the pump down. 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 Key7588790
MDR Text Key110673256
Report Number3004209178-2018-13118
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/06/2018
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: 06/11/2018 Patient Sequence Number: 1
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