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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 Problems Fluid Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Scar Tissue (2060); Fluid Discharge (2686); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2021, product type: catheter. Product id: 8784, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 03-may-2019, udi#: (b)(4); product id: 8784, serial/lot #: (b)(4), ubd: 15-apr-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient receiving dilaudid 10mg/ml at 2. 75mg/day via an implantable pump. It was reported that the patient had a scab on her pump pocket site, that when it sloughed off had a bit of drainage come through. The patient also noticed itching. The environmental, external or patient factors that may have led or contributed to the issue was noted as ¿n/a¿. The diagnostics and troubleshooting performed was the healthcare provider did a catheter access study and found dye to be leaking from the collet. The healthcare provider scheduled this case as a catheter revision then found the infection when he opened the pocket. The actions and interventions taken to resolve the issue was a full system explant. The issue was resolved at the time of the report and it was noted as the healthcare provider would not have any further information regarding the 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12383489
MDR Text Key268651452
Report Number3004209178-2021-13050
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2017
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: 08/30/2021 Patient Sequence Number: 1
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