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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 Filling Problem (1233); Increase in Pressure (1491)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal baclofen 2000 mcg/ml at 216 mcg/day via an implantable pump. The indication for use was not reported. It was reported an issue occurred during the refill procedure. The physician found resistance to inject the drug inside the reservoir. The total amount of drug injected was 13 ml. The hcp waited for about 20 minutes. Then, the hcp removed all the drug inside the reservoir (and air), but when the new refill was performed, the issue occurred again. The hcp decided to end the procedure, and he programmed the pump with 13 ml in the reservoir. It was noted that a refill kit from the device manufacturer was used during the procedure, and the drug was injected slowly to avoid activating the valve. The issue was not resolved. However, the patient's status was alive - no injury. The pump remained implanted and in service. The physician decided to monitor the situation, and he would update the device manufacturer on the next refill date. No surgical intervention occurred or was planned. Information regarding the pump implant date was unavailable. Information regarding the patient¿s gender, age, weight, medical history, and other medications was unavailable. 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 a foreign healthcare professional (hcp) via a manufacturer representative. It was reported the patient had gone scuba diving (20 m below sea level). The physician had not decided if they were going to explant the pump; the physician was evaluating pump replacement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative. It was reported that the pump would be replaced but the physician had not scheduled the replacement date yet.
 
Manufacturer Narrative
The aware date of new information received by the manufacturer in supplemental report 003 was (b)(6) 2020 (not (b)(6) 2019). 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 foreign manufacturer representative. It was reported that the pump was explanted.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key8857700
MDR Text Key162810197
Report Number3004209178-2019-14919
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2017
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: 08/02/2019 Patient Sequence Number: 1
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