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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 Infusion or Flow Problem (2964); Insufficient Information (3190)
Patient Problem Foreign Body Reaction (1868)
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-aug-2019, 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 gablofen (2000 mcg/ml at 1600 mcg/day) via an implanted pump. The indication for pump use was cerebral palsy and intractable spasticity. It was reported that the patient was taken in for a catheter revision. When they opened the pump pocket, there was scar tissue over the pump connector. They were not able to aspirate from the cap (catheter access port). When they did surgical exploration, they found that the catheter anchor was not in place either. The pump and catheter were replaced. The issue was noted to be with the catheter and not the pump.
 
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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 Key14344835
MDR Text Key291276301
Report Number3004209178-2022-05943
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,Followup,Followup
Report Date 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2017
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: 05/10/2022 Patient Sequence Number: 1
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