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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 Problem Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Date 07/02/2021
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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (500 mcg/ml at 170 mcg/day) via an implantable infusion pump. It was reported overdose occurred. The event date was reported to be (b)(6) 2021. The reservoir volume of the pump was checked and there was a difference. The pump was filled with new [drug] and after a while the reservoir volume was less than it should be. The pump was explanted on (b)(6) 2021. During the surgery, the physician checked the volume in the pump again. It should have been 19. 4 ml, but they only extracted 6 ml. The pump had been filled on (b)(6) 2021 with 20 ml nacl. The pump would be returned. There were no reported contributing factors. The patient status was alive - no injury. Further complications were not reported. Additional information was received. It was stated the pump delivered more than eight times the [expected volume] and was considered a danger to life. It is not suspected a pocket fill resulted in the volume discrepancy, as the physician checked during the refill. Leaking from the pump reservoir septum was not observed during explant. The event was considered 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12169616
MDR Text Key261727474
Report Number3004209178-2021-10854
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/17/2018
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: 07/14/2021 Patient Sequence Number: 1
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