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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 Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)
Patient Problems Itching Sensation (1943); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 05/24/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative on (b)(6) 2018 regarding a patient receiving unknown baclofen (dose and concentration unknown) via an implanted infusion pump. The indications for use included intractable spasticity and other spasticity. It was reported that the patient reported to her neurologist and family that she felt the pump stopped working, and she had to take oral baclofen. It was noted that the pump would be interrogated in the near future. No actions or interventions were taken to resolve the issue, and it was unknown if the issue was resolved at the time of report. No surgical intervention was planned or scheduled, and the patient's status at the time of report was alive - no injury. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the company representative (rep) indicated the date of the event was (b)(6) 2018. It was noted the pump was interrogated and the logs would be forwarded. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative (rep) indicated the patient was experiencing an intermittent itching feeling which was a sign of withdrawal and that the itching went away just after a pump refill. On (b)(6) 2018, the patient woke up with itching all over their body. The last pump refill was (b)(6) 2018, and nothing had been done with the pump since then. There were no motor stalls/anomalies confirmed via the event logs. The rep was calling to troubleshoot the issue like checking patency of the catheter, checking the drug compounding from the pharmacy, but the caller did not know if the drug was compounded or not. It was confirmed with the healthcare provider (hcp) that during the last pump refill there was maybe a little more drug then expected, but had no actual figures. The rep would confer with the hcp and the patient. The event date for the volume discrepancy reported was (b)(6) 2018, and the patient had itching and withdrawal symptoms on (b)(6) 2018. No further complications were reported/anticipated or expected.
 
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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 Key7601715
MDR Text Key111154459
Report Number3004209178-2018-13437
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
Type of Report Initial,Followup,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/22/2016
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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