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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving 500mcg/ml prialt at 25mcg/day via an implantable infusion pump for an unknown indication for use. It was reported that the patient had been in the emergency room because they were confused, disoriented, and could not maintain their balance. The patient was recently refilled with 500mcg/ml prialt on (b)(6) 2018. The pump was interrogated which showed no issues. The pump was programmed to minimum rate. It was unknown if the issue was resolved at the time of the report. The patient's spouse reported that this had happened before back in (b)(6) 2018. The patient's status was noted as "alive-no injury. " no further complications were anticipated/reported. On 2018-11-09 (hcp): additional information was received from a healthcare professional (hcp). It was reported that the prialt dose was given to the patient and they were monitored in the recovery room for 120 minutes. It was reported that 12 hour post procedure the patient was taken to the er by ambulance for hypotension and hallucinations. The hcp reported that the patient only had a trial of prialt but the initial information sent reported that the patient had 500mcg/ml prialt in the pump and there was no indication of a trial, this is being noted as it is conflicting information. It was reported that the patient had been admitted to the hospital for 9 days. The patient had preexisting medical conditions of hypertension, high cholesterol, depression, and gout. It was reported that the patient adverse events recovered/resolved. No further complications were anticipated/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
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8096467
MDR Text Key128116413
Report Number3004209178-2018-26080
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/12/2018
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: 11/21/2018 Patient Sequence Number: 1
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