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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 Problems No Audible Alarm (1019); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)
Patient Problems Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare provider (hcp) regarding a patient receiving gablofen (200 mcg/ml at 1000 mcg/day) via an implantable infusion pump. The indication for use was intractable spasticity. It was reported that a refill was performed on (b)(6) 2019 and the elective replacement indicator (eri) was shown to be 33 months but on (b)(6) 2019 and the hcp used the tablet for the first time with the patient and in the logs it noted that eri had occurred on (b)(6) 2019. The caller stated the patient and their caregiver had not heard any alarms. No symptoms were reported. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Additional review of the provided information indicated that this section needed to be updated. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the pump was replaced on (b)(6) 2019 and would be returned. The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury. ¿ the patient¿s weight and medical history were asked but unknown. It was also indicated the patient was receiving intrathecal lioresal (concentration and dose unknown). No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Analysis of the pump found ¿pump - voltage related eri or eos - undetermined cause¿ and ¿pump ¿ low battery reset ¿ undetermined cause¿. 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 Key9071371
MDR Text Key162275074
Report Number3004209178-2019-17717
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2015
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: 09/16/2019 Patient Sequence Number: 1
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