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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 Insufficient Information (3190)
Patient Problems Bronchitis (1752); Dyspnea (1816); Overdose (1988); Complaint, Ill-Defined (2331); Malaise (2359); No Code Available (3191)
Event Date 02/15/2018
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 healthcare provider via a clinical study regarding a patient receiving dilaudid (1. 0 mg/ml at 0. 2654 mg/day) and bupivacaine (30. 0 mg/ml at 7. 963 mg/day) via an implanted pump. The indication for use was non-malignant pain and lumbar radiculopathy. It was reported the patient was not feeling well, short of breath, and "not safe" on (b)(6) 2018. The patient was fearful the pump was malfunctioning or causing an overdose. A ct scan was performed on (b)(6) 2018 and revealed bronchiectasis. The clinical diagnosis was possible it medication side effects. It was indicated the event was possibly related to the device or therapy and possibly related to the drug hydromorphone and bupivacaine. The pump was reprogrammed and the it rate was decreased by 25%. The patient was encouraged to follow-up with a pulmonologist. The issue resolved without sequelae on (b)(6) 2018. Additional information stated the patient was afraid the pump was malfunctioning but this was not confirmed. The cause of the pump malfunction and overdose was not determined. The patient's weight was (b)(6).
 
Manufacturer Narrative
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 Key7671551
MDR Text Key113501294
Report Number3004209178-2018-15333
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2017
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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