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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 Migration or Expulsion of Device (1395); Insufficient Flow or Under Infusion (2182)
Patient Problems Fall (1848); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Type  Injury  
Event Description
Information was received from a consumer via a manufacturer representative regarding a patient who was receiving gablofen (1000mcg/ml at 120mcg/ml) via an implantable pump for intractable spasticity. It was reported that patient reported legs feeling extremely heavy approximately two months ago. At last refill three weeks ago, residual volume and actual volume were off, 2mg expected and 13mg returned. The physician went up once on dose with no improvement. Patient reported many falls and difficulty/issues getting out of bed and moving each morning. The medication dose was increased and the pump segment was revised. The connector and portion from collet to pump were replaced. The issue was resolved at time of this report, patient status was alive no injury.
 
Manufacturer Narrative
Concomitant medical products: product id 8780. Serial# (b)(4). Product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 06-aug-2023, udi#: (b)(4). 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 Key14069785
MDR Text Key288992402
Report Number3004209178-2022-04479
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/23/2021
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: 04/11/2022 Patient Sequence Number: 1
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