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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); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 11/30/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8835, serial#: unknown, product type: programmer, patient. Other relevant device(s) are: product id: 8835, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient and a healthcare professional (hcp) via a manufacturer's representative (rep). The patient was receiving an unknown concentration of bupivacaine at 1. 999mg/day and an unknown concentration of morphine at 0. 1199mg/day via an implantable infusion pump for non-malignant pain. It was reported that patient's hcp turned up the infusion rate. The non-critical alarm went off and the patient programmer (ptm) said "low reservoir. " the critical alarm started going off because the pump was empty. The pump had been empty since (b)(6) 2019. The pump was flushed with saline, and then filled with morphine on (b)(6) 2019. After the refill the patient wasn't getting any relief from the pump. The volume of the reservoir was going to be checked. The patient reported that there is a ptm bolus request that is not accurate. The ptm will show that a bolus is delivered when they haven't been requested. The refill date on the ptm was also not accurate. No symptoms were reported. It was unknown if the issue was resolved, and the patient's status was noted as "alive-no injury. " no further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from an hcp on 2019-dec-24. It was reported that the instance of the patient being given a bolus even though one had not been requested was not confirmed to have occurred. The cause of the empty pump was administrative, and the pump was refilled. The lack of pain relief was resolved.
 
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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 Key9460265
MDR Text Key179331973
Report Number3004209178-2019-23705
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
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 Received12/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/07/2019
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

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