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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 12/07/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8711, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2020, product type: catheter.Product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: catheter.Product id: 8709, lot#: j0039909r, implanted: (b)(6) 2000, explanted: (b)(6) 2020, product type: catheter.Product id: 8711, serial/lot #: (b)(4), ubd: 27-feb-2009, udi#: (b)(4).Product id: 8598a, serial/lot #: (b)(4), ubd: 24-apr-2020, udi#: (b)(4).Product id: 8709, serial/lot #: (b)(4), ubd: 24-apr-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump.It was reported per the hcp, the patient had an abscess ad it was decided to remove the pump and catheter.It was unknown what factors may have led or contributed to the issue.No diagnostics/troubleshooting was performed.Actions/interventions included surgical interventions where the complete pump system was explanted due to infection on (b)(6) 2020.It was noted that all of the devices were sent to pathology and then will be discarded per hospital protocol.It was noted that the issue was resolved at time of report.The patient's status at time of report was asked but unknown.It was noted the patient's weight and medical history were asked and will not be made available.The event date was (b)(6) 2020.No further complications were reported/anticipated.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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 Key10977981
MDR Text Key221449985
Report Number3004209178-2020-21507
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630512
UDI-Public00643169630512
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,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/09/2020
Date Device Manufactured03/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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