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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 Obstruction of Flow (2423); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Muscular Rigidity (1968)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8784 serial# (b)(4) implanted: (b)(6) 2020 explanted: (b)(6) 2022 product type catheter product id 8780 serial# (b)(4) implanted: (b)(6) 2014 explanted:(b)(6) 2022. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 21-feb-2022, udi#: (b)(4) ; product id: 8780, serial/lot #: (b)(4), ubd: 15-oct-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving gablofen (2000 mcg/ml at 605 mcg/day) via an implantable pump for intractable spasticity. It was reported that the patient has had increasing tone for ¿a number of months¿ which has resulted in higher doses. There were no factors that may have led or contributed to the issue. Logs were read (nothing abnormal noted) and no additional troubleshooting done per patient. Intra-operation aspiration of the catheter via cap (catheter access port) was successful. The catheter was also cut in a few spots showing flow at each cut. When the catheter was removed from the intrathecal space, it was noted there appeared to be a kink at the anchor site as well as a squiggly looking spinal segment. The hcp thought that may have been a contributing factor to inconsistencies in therapy. The patient had a full system replacement. The issue was resolved at the time of report. The patient's medical history was asked and will not be made available. The patient's status at the time of report was alive - no injury.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13998685
MDR Text Key289182900
Report Number3004209178-2022-04219
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2020
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: 04/04/2022 Patient Sequence Number: 1
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