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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 Obstruction of Flow (2423)
Patient Problems Headache (1880); Nausea (1970); Chills (2191); Sleep Dysfunction (2517)
Event Date 02/01/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter. Product id: 8731sc, serial#: (b)(4), implanted: (b)(6) 2008, product type: catheter. Product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2011, product type: catheter. Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 15-jan-2017, udi#: (b)(4); product id: 8731sc, serial/lot #: (b)(4), ubd: 02-sep-2010, udi#: (b)(4) ; product id: 8596sc, serial/lot #: (b)(4), ubd: 05-feb-2013, udi#: (b)(4). (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2020-apr-20, information was received from a patient receiving dilaudid (unknown dose and concentration) via an implantable pump for non-malignant pain. The patient reported they did not think their pump was working properly. The patient fell in february, and thought she "cramped the tubing". Since (b)(6), the patient has been having a headache, nausea,vivid dream, and "her smell and taste are going". The patient stated they were not in full blown withdrawal but could not function properly. The patient was sick, stating, "it is like you got the flu". The patient had to stay in bed now. It was also noted the patient had chronic obstructive pulmonary disease (copd) and it was affecting her breathing because of the condition. The patient went to the er in (b)(6), and asked them to do a drug screening and she had no medicine in her. The patient was told that "it does not show up", but the patient knew it does show up when they did drug testing in the office. The hcp used a tablet on the patient/pump, and told the patient the pump was working and that the tablet said the pump is working. The patient was redirected to speak with their hcp. The patient then said they would really insist because they were "ready to jump in front of the bus" and could not keep doing this. The patient did not know the dose and concentration of dilaudid and stated it was 10 mg, then she said it was very low (thought only 10%).
 
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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 Key10001088
MDR Text Key189014387
Report Number3004209178-2020-07730
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
Type of Report Initial,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/26/2016
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: 04/27/2020 Patient Sequence Number: 1
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