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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 Insufficient Information (3190)
Patient Problems Erythema (1840); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)
Event Date 03/01/2022
Event Type  Injury  
Event Description
Information was received from a consumer via a manufacturer representative regarding a patient who was receiving unknown own drug v ia an implantable pump for intractable spasticity. It was reported that the patient was having redness and pain at the pump site and unsure if pump working. Patient was unaware of factors that had led to the issue.  a dye study was supposed to be done but they didn¿t want to access pump due to swelling and scab at pump site. The provider was going to do needle aspiration of fluid in pump pocket. They discussed weaning down baclofen and potentially explant pump or whole system. The issue was not resolved. The patient status was alive no injury.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
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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 Key14270457
MDR Text Key290806304
Report Number3004209178-2022-05544
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 Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/13/2021
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: 05/03/2022 Patient Sequence Number: 1
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