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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 Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)
Patient Problems Overdose (1988); Therapeutic Response, Decreased (2271); Sedation (2368); Confusion/ Disorientation (2553)
Event Date 05/21/2018
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 professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving dilaudid, unknown concentration at 0. 8 mg dose via intrathecal drug delivery pump for spinal pain. It was reported that it seemed pump delivered too much medicine. No environmental/external/patient factors that may have led or contributed to the issue were known. The hcp looked at logs and rechecked her calculations. Everything appeared normal. Patient was sent to emergency room and admitted to hospital. Electrocardiogram (ekg) was completed as well as other tests. Pump put in minimal rate. By this morning, patient was in withdrawal. Patient's pump was started back up this morning and patient went into an overdose situation. Pump was stopped and drug withdrawn and only 18cc in pump. They weren't sure what they were going to do. The rep was getting information over the phone- the hcp was aware of situation. They were trying to plan a course of action. Pump was stopped and empty. Surgical intervention did not happen and it was unknown if it was planned. At the time of this report, the issue was not resolved and patient status was alive-with injury, shortly after refill patient found by emergency medical response wondering in the hall of hospital and she was disoriented. No further complications were reported. The patient¿s medical history included some baseline confusion/dementia.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). It was reported that the letter that they sent was incorrect in the sequence of events. No further complications were reported.
 
Manufacturer Narrative
Corrected information. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). It was reported that pump was refilled on (b)(6) 2018- dilaudid 5 mg/ml at a dose of 0. 5 mg/day. Within 5-10 minutes of the pump refill, the patient began to experience confusion and sedation. Rapid response involved and patient subsequently sent to emergency room for continued case. Pump turned to minimum rate (b)(6) 2018 around 7:20 pm. On (b)(6) 2018- reservoir assessed prevrealing 18 cc medication in the reservoir with expected volume
=
20ml. Medication removed from the reservoir and pump stopped. Patient continued to exhibit confusion with macular generation (amd) and required prolonged hospitalization. Patient was discharged from hospital on (b)(6) 2018. Patient was seen in office on (b)(6) 2018 and pump was turned off. The issue had been resolved. The cause of delivering too much medication was unknown-possible malfunction of internal tubing or occlusion rotors. 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 Key7538165
MDR Text Key109051886
Report Number3004209178-2018-11673
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 05/23/2018 Patient Sequence Number: 1
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