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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); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2022
Event Type  Injury  
Manufacturer Narrative
Product id: 8780; serial#: (b)(4); implanted: (b)(6) 2022; product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 07-oct-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a company representative regarding a patient receiving dilaudid 2mg/ml at 0. 35mg/day via an implantable pump. It was reported that the patient described withdrawal symptoms and has fluid accumulation at the incision. The environmental, external or patient factors that may have led or contributed to the issue was the patient had a recent revision of the spinal segment. The diagnostics and troubleshooting performed was the physician performed a dye study which showed no leaks. They were able to aspirate the catheter and also drew off 2 cc¿s of fluid from the incision. The actions and interventions taken to resolve the issue was the healthcare provider increased the patient¿s daily dose from 0. 22 mg to 0. 35mg. The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information 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 Key14453923
MDR Text Key293008124
Report Number3004209178-2022-06456
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 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
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 Received05/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/02/2021
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: 05/20/2022 Patient Sequence Number: 1
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