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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 Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problems Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (2,000 mcg/ml, 313 mcg/day) from an implantable pump for intractable spasticity. On (b)(6) 2018, the patient had an magnetic resonance imaging (mri) performed due to lower extremity osteomyelitis. A motor stall was seen on initial interrogation. Logs were inspected and a motor stall recovery has not occurred. It was noted that the patient left the mri field more than two hours prior. Additional information was provided that indicated the pump stall had recovered (date not provided). The actions taken to resolve the event were; pump interrogation and medication management. The reported cause of the stall was the mri. It was also noted that the patient did present with spasticity a couple times since the mri. The dates were (b)(6) 2018. It was noted that they presented to the emergency department (ed) "primary for other indications, with secondary complaints of spasticity". Discrepant information was received from the rep that stated the mri occurred and stall occurred on "(b)(6)". Follow up is being performed to clarify the discrepancy.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(4) 2018, additional information was received from the rep. The rep clarified that the correct date for the motor stall and mri was (b)(4) 2018. The rep also reported that the 'other indications' the patient presented to the emergency room were related to osteomyelitis.
 
Manufacturer Narrative
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 Key7739684
MDR Text Key116259880
Report Number3004209178-2018-17156
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 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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