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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 Problems Aspiration Issue (2883); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erythema (1840); Unspecified Infection (1930); Pain (1994); Seroma (2069); Swelling (2091); Fluid Discharge (2686)
Event Date 06/13/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider (hcp) via a clinical study indicated the infection was confirmed. Laboratory testing of a wound culture on (b)(6)2017 was positive for infection. The exact cause of the infection/seroma was not noted. The outcome was 'unresolved at the time of study exit/death/study closure. '.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2017-oct-27, additional information was received from a healthcare professional (hcp) via a clinical study. It reported the patient/subject was exited from the study on (b)(6)2017. The reason for exit was all enrolled manufacturer products were inactive. No further complications were reported/anticipated.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient receiving morphine with an unknown dose and concentration via an implantable pump for non-malignant pain. It was reported via a clinical study the patient was diagnosed with a hardware infection at the pump pocket site. The patient presented on (b)(6) 2017 with incisional pain/swelling at the pump site. A seroma was noted and they were unable to aspirate/tried to aspirate but were unsuccessful on (b)(6) 2017. The pump was reprogrammed and the rate was increased on (b)(6) 2017. Examination on (b)(6) 2017 showed there was no signs/symptoms of infection. On (b)(6) 2017 it was reported the patient had/developed urinary tract infection symptoms, was seen by hcp, and labs were ordered. The results of the labs were unknown. On (b)(6) 2017 the patient reported having clear fluid leakage at the pump site noted at 10am (in the morning) per patient with abdominal pain only at the pump site (where pump was located). Examination on (b)(6) 2017 showed that there was a possible pump infection at the pump site, a broad spectrum of antibiotics were given, and the patient was admitted to the emergency room. Interventions included explanting (not replacing) the entire system on (b)(6) 2017 due to hardware infection. Examination on (b)(6) 2017 showed there was no signs/symptoms of infection. On (b)(6) 2017, the patient reported redness at the incision site with clear drainage. Medication, bactrim ds, was administered/prescribed on (b)(6) 2017. The event required in-patient or prolonged hospitalization. It was noted that the relationship of the event to the device or therapy was possible related, and the relationship of the event to the implant procedure was possibly related. The event was ongoing. No further complications were reported/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 Key6941033
MDR Text Key101742666
Report Number3004209178-2017-21619
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/20/2017
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: 10/11/2017 Patient Sequence Number: 1
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