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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 Problem Infusion or Flow Problem (2964)
Patient Problems Fall (1848); Dizziness (2194); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sweating (2444)
Event Date 05/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, lot# n287656003, implanted: (b)(6) 2011, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer via a device manufacturer representative regarding a patient receiving dilaudid (20 mg/ml at 3 mg/day) and bupivacaine (20 mg/ml at 3 mg/day) via an implantable infusion pump. It was reported that about 2 weeks ago the patient's pain relief began fading and a lump formed on the lateral side of her spinal incision. It was noted that no falls had occurred prior to the issue but that the past weekend she had fallen due to feeling dizzy. Allegations of the patient waking up at night with the sweats was also reported. A dye study was performed and the healthcare provider (hcp) was unable to aspirate any fluid from the catheter access port (cap). It was determined that the patient needed a catheter exploration and a revision/replacement was scheduled. The issue was unresolved and the patient was alive with no injury. No further complications have been reported as a result of this 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8678048
MDR Text Key147299004
Report Number3004209178-2019-11110
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,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/11/2017
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: 06/07/2019 Patient Sequence Number: 1
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