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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 Bacterial Infection (1735); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033); Discomfort (2330); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446)
Event Date 09/16/2018
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 patient via a manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device. The drug being delivered was unknown. The reason for use was not reported. It was reported that the pump was explanted on (b)(6) 2018 because the patient was experiencing a skin rash around pump. There was stated to be possible infection or allergic reaction to titanium. There were no environmental/external/patient factors that may have led or contributed to the issue. Diagnostics/troubleshooting included specimens that were collected and sent for analysis for possible infection. The rep was in possession of the device to be returned to the manufacturer for analysis. It was unknown if a device was replaced by one of the same manufacturer. The issue was resolved at the time of the report, and the patient status was listed as ¿alive ¿ no injury. ¿ there were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep on 2018-oct-25. It was reported that there was a red rash on the skin outlining the bottom of the pump. The infection or the allergic reaction were not yet confirmed. Samples for infection have been sent to a lab. Physician may recommend patient test for titanium allergy. The device was mailed on 2018-(b)(6) with no tracking number. There were no further complications reported/anticipated.
 
Manufacturer Narrative
The pump was returned, and analysis found no anomaly of the pump. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the patient was receiving compounded morphine 1. 0 mg/cc for a total dose of 0. 3469 mg/day. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2019. It was noted the event date was corrected to (b)(6) 2018.
 
Manufacturer Narrative
Patient code (b)(4) no longer applies to the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via clinical study indicated the patient's cultures were positive for pseudomonas. The clinical diagnosis was updated to wound infection. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the patient was receiving compounded morphine with an unknown dose and concentration. It was reported on (b)(6) 2018 the patient experienced soreness and redness at the right lateral corner of the pump incision. Examination on (b)(6) 2018 confirmed redness at pump incisional site. It was noted the pump was not replaced. The outcome of the event was noted as ongoing. The clinical diagnosis was induration at right lateral corner of incision site. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. The incisional site/device tract was pump pocket. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated possible infection was added to the clinical diagnosis. It was noted the system was removed secondary to infection. It was determined the patient had a slight infection versus an allergic reaction. No further complications were reported/anticipated.
 
Manufacturer Narrative
Event description updated to reflect the information received on 2018-dec-20. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study on 2018-dec-20. It was reported that the patient's infusion mode was set to flex dosing as of (b)(6) 2018. No further complications were reported or anticipated.
 
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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 Key8006021
MDR Text Key125036841
Report Number3004209178-2018-23931
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530126
UDI-Public00643169530126
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,Followup,Followup,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2017
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: 10/25/2018 Patient Sequence Number: 1
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