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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 Problem Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 02/17/2022
Event Type  Injury  
Manufacturer Narrative
Continuation of concomitant medical products: product id 8780 , serial# (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter , ubd: 03-may-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving morphine (1 mg/ml at. 075 mg/day) via an implanted pump. It was reported that the patient stated she was ¿almost experiencing a dam-like effect where the drug would build in the catheter and created bulge in her back and then release causing her to receive too much medication¿. The hcp attempted to aspirate the catheter but was unsuccessful. The hcp decided to completely explant the old catheter and re-implant a new one. There were no environmental, external, or patient factors that may have led or contributed to the issue. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14469245
MDR Text Key292360870
Report Number3004209178-2022-06576
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/11/2019
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: 05/23/2022 Patient Sequence Number: 1
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