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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930); Muscle Weakness (1967); Dysphasia (2195); Loss of consciousness (2418); Diaphoresis (2452); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 01-apr-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional (hcp) regarding a patient receiving hydromorphone (1. 5 mg/ml at 0. 9985 mg/day) and bupivacaine (5. 2 mg/ml at 3. 4614 mg/day) via an implantable infusion pump. It was reported that the patient's whole pump system was removed due to a wound infection in their abdomen. No further complications were reported.
 
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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
MDR Report Key12085128
MDR Text Key265008316
Report Number3004209178-2021-10113
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630512
UDI-Public00643169630512
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2020
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: 06/29/2021 Patient Sequence Number: 1
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