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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 Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)
Patient Problems Fall (1848); Muscle Weakness (1967); Overdose (1988)
Event Date 07/25/2018
Event Type  Injury  
Manufacturer Narrative
Occupation: healthcare professional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal compounded baclofen 1000 mcg/ml at 153 mcg/day via an implantable pump. The indication for use was not reported. It was reported that there was a possible suspicion of over-infusion. As of (b)(6) 2018, the patient fell three times last week (muscle weakness). The patient was hospitalized. The hcp suspected over-infusion because he could not find anything else that might have caused this to happen. The pump was ¿twicely reduced with 10%¿. The daily dose was reduced from 153 mcg/day to 122 mcg/day. The patient was stable, and the patient's status was alive - no injury. However, it was unknown if the issue was resolved. It was noted that in weeks following the patient¿s last refill on (b)(6) 2018, nothing seemed wrong. The manufacturer representative asked the hcp for volume discrepancies, but the hcp said ¿volumes were too small to say anything about this¿. There were no applicable environmental, external or patient factors reported that might have led or contributed to the event. Diagnostics/troubleshooting indicated logs were clean. Surgical intervention did not occur and was not planned. The patient¿s medical history included an ambulatory stroke. The implant date was unknown. Patient weight and age were unavailable. No further complications were reported.
 
Manufacturer Narrative
Corrected information. 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 foreign healthcare professional (hcp) via a manufacturer representative. It was reported an 8840 clinician programmer was used to program the pump. It was noted that the hcp¿s measuring method was ¿not accurate enough¿ to determine if the pump was overinfusing more than 14. 5% as they had 20 cc syringes. The neurologists had ruled out a new cardiovascular accident. The hcp wanted to report that it would be possible the pump overdosed. The hcp had no other explanation. When they refilled the pump, they made the most exact analysis of the residual volume (calculated/real). The hcp keep adjusting the pump (down) ¿whilst [the patient] was stable before¿.
 
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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 Key7742043
MDR Text Key115784203
Report Number3004209178-2018-17223
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
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