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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 Problem Difficult to Insert (1316)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter. Product id: 8782, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter. Product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a healthcare provider (hcp) via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver gablofen [3000 mcg/ml to 500 mcg/ml] at 819 mcg/day, indicated for intractable spasticity and cerebral palsy. It was reported that a difficulty occurred intra-operatively on (b)(6) 2018 during a intrathecal baclofen (itb) replacement case. It was reported that the patient was ¿fused head to toe¿ and that they had been working for an hour on the spinal segment with no success. It was stated that they were leaving the catheter as is and would come back at a later time to try and correct the issue. It was noted that existing catheter volume was 0. 151 ml, and the 41. 9 cm spinal segment "0. 09218. " the proximal piece of the catheter was attached to the pump and a back-table prime was done with the 500 mcg/ml of 0. 306 mls. The existing spinal segment had 3000 mcg/ml. No medical symptoms were reported. Additional information was received from a manufacturer's representative on (b)(6) 2018. The surgeon attempted to introduce a new catheter; however, the patient has hardware from cervical spine to sacrum. Ultimately, they decided to just reconnect the existing catheter, as they were unable to get a needle into the intrathecal space. The surgeon wanted to monitor the patient overnight. It was stated that the patient was discharged on saturday ((b)(6) 2018) and was recovering. The patient's weight at the time of the event is unknown. 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 healthcare provider (hcp) via a manufacturer¿s representative on 2018-jul-19. It was reported that the cause of the difficulty inserting the catheter was the patient's implanted spinal hardware and "fusion mass" per the hcp. No further surgical intervention was planned at the time of the report. No further complications were reported.
 
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 Key7627217
MDR Text Key111973300
Report Number3004209178-2018-14057
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
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2019
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 Manufactured02/14/2018
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: 06/21/2018 Patient Sequence Number: 1
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