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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 Material Integrity Problem (2978)
Patient Problems Scar Tissue (2060); Seroma (2069)
Event Date 04/21/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (2000 mcg/ml at 256. 7 mcg/day) via an implantable pump for intractable spasticity. It was reported that the pump was replaced due to expected end of life (eol). Upon exposing pump pocket site, neurosurgeon observed a small amount of clear fluid. Scar tissue had formed around the catheter and after teasing scar tissue away, it was observed the catheter had a small tear in it immediately above the sutureless connector. After cutting the catheter above the tear, a new segment of 8784 was spliced onto existing catheter. No factors have led to the event. It was reported that  infusion rate of pump was decreased from 256. 7 g per day to 200 g per day. Patient was admitted overnight for observation and rehabilitation team will assess patients to see if further titration was required. The issue was resolved at the time of this report. Patient medical history include stoke, type two diabetes, pulmonary hypertension, right spastic increases, dysarthria, neck fracture with orif surgery done. Patient was alive no injury.
 
Manufacturer Narrative
Continuation of concomitant medical products: product id 8781, serial# (b)(4), product type: catheter, ubd: 09-jul-2017, udi#: (b)(4). 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14219440
MDR Text Key290163895
Report Number3004209178-2022-05315
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
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/06/2015
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: 04/27/2022 Patient Sequence Number: 1
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