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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 Kinked (1339); Aspiration Issue (2883)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 05-nov-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving dilaudid (15 mg/ml at 5 mg/day) and bupivacaine (15 mg/ml at 5 mg/day) via an implantable infusion pump. The indications for use were noted to be non-malignant pain and failed back surgery syndrome. It was reported that the patient complained to the doctor about a lack of pain relief. The hcp tried to aspirate through the side port but was unable to do so and determined the catheter was kinked. The catheter was replaced on (b)(6) 2018. There were no environmental, external or patient factors which may have led or contributed to the issue. The patient's status at the time of the report was alive - no injury. The issue was considered resolved. No further complications were reported.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter. Analysis observed a kink in the body of the catheter. If information is provided in the future, a supplemental report will be issued.
 
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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 Key7490891
MDR Text Key107486815
Report Number3004209178-2018-10243
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 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2015
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: 05/07/2018 Patient Sequence Number: 1
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