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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 Fall (1848); Overdose (1988); Numbness (2415); Ambulation Difficulties (2544)
Event Date 08/15/2018
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 provider (hcp) and from a consumer via a manufacturer's representative (rep) regarding a patient who was receiving 15 mg/ml of fentanyl at 1. 793 mg/day, 4 mg/ml of marcaine at 0. 4782 mg/day, and 1. 1 mg/ml of ketamine at 0. 1315 mg/day via an implantable pump for other chronic/intractable pain (trunk/limbs) and spinal pain. On (b)(6) 2018, it was reported that the patient had an overdose. The patient reported that they fell on the morning of (b)(6) 2018 and was seen in the er. The patient stated that their feet were numb and they lost their balance. According to the patient, their feet frequently go numb and cause them to fall. At the er, the hcp reported that the patient was showing signs of overdose. A rep interrogated the patient's pump and found that it was working normally. No actions/interventions were taken to resolve the issue. No surgical intervention had occurred nor was a surgical intervention planned. The issue was considered resolved at the time of the report. No further complications were reported. The patient¿s medical history included seizure, high blood pressure, and chronic pain.
 
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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 Key7837935
MDR Text Key118926284
Report Number3004209178-2018-19684
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,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2017
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 Received08/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/05/2015
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: 08/31/2018 Patient Sequence Number: 1
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