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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 Device Alarm System (1012); Protective Measures Problem (3015); Data Problem (3196)
Patient Problems Malaise (2359); Numbness (2415)
Event Date 03/28/2018
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 health care provider (hcp) regarding a patient receiving bupivacaine (25 mg/ml at 13 mg/day) and baclofen (65 mcg/ml at 34 mcg/day). The indications for use were noted to be non-malignant pain and complex regional pain syndrome type 1. It was reported that a critical alarm was heard by the patient on (b)(6) 2018. She came into the office the next day and pump interrogation showed the pump in safe state, but it showed no reset. The logs showed the safe state occurring on (b)(6) 2018 at 13:36. The hcp tried to reset the pump but it went back into safe state. It was reviewed that the pump would likely have to be replaced and returned for analysis. The patient reported her leg went numb and she was "not feeling well. " no further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative (rep) indicated surgery was scheduled for (b)(6) 2018 and the pump would be returned for analysis. No further complications were reported.
 
Manufacturer Narrative
Analysis of the implantable infusion pump (b)(4) found a high current drain of unknown cause and bit flip/task id in task record. (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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7384969
MDR Text Key103940022
Report Number3004209178-2018-06086
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,Followup,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2014
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: 03/30/2018 Patient Sequence Number: 1
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