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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 Abdominal Pain (1685); Erythema (1840); Unspecified Infection (1930); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional (hcp). It was unknown if the pump will be returned to the manufacturer.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional (hcp). The pump was out. The hcp would not be addressing for six months in regard to re-implanting the pump to make sure the infection was clear.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a company representative. The explanted device will not be returned to the manufacturer.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional (hcp). It was reported that the patient first start experiencing the infection on (b)(6)2017. The infection was observed on (b)(6)2017 by medical professionals. Per patient, he noted redness since pump was placed in (b)(6) 2017. Wound opened on (b)(6)/2017 with drainage. It was reported that the patient had a symptom of pain over incision abdomen. Patient was taken to operating room for removal of pump on the same date. Patient was currently on iv antibiotic. Patient's weight at the time of the event was estimated to be (b)(6). Patient's medical history was reported to be chronic low back pain (lbp)/ sciatica, chronic obstructive pulmonary disease, high blood pressure (htn), crohn's and obstructive sleep apnea (osa). No further complications were reported.  .
 
Event Description
Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving an unknown medication via an implantable pump. Indication for use was spinal pain. The date of the event was unknown. It was reported the patient experienced a pump infection. It was unknown if the infection was related to the device. It was unknown how far the infection had tracked. It was planned to explant the pump on (b)(6) 2017 and possibly ligate the catheter. No further complications were reported.
 
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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 Key6912919
MDR Text Key101896271
Report Number3004209178-2017-20576
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,Followup,Followup,Followup
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received10/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/30/2017
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: 10/03/2017 Patient Sequence Number: 1
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