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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 Mechanical Problem (1384); Failure to Disconnect (2541); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products:product id 8785 lot# (b)(4) serial# implanted: (b)(6) 2015 explanted: (b)(6) 2022 product type catheter. Product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: (b)(6) 2022 product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 04-aug-2017, udi#: (b)(4). Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen (2000 mcg/ml at 1168 mcg/day) via an implanted pump. The patient¿s medical history included spastic quadriplegia secondary to a non-accidental traumatic brain injury, spasticity, dystonia, oropharyngeal dysphasia, tracheostomy, left spastic hip dysplasia, seizure like activity, visual impairment, and global functional impairment. The patient¿s concomitant medications included oral baclofen, clonidine, cyproheptadine, estradiol, and gabapentin. The indication for pump use was intractable spasticity. It was reported that during the routine pump replacement procedure for eol (end of life), the hcp had difficulty removing the sutureless connector from the existing pump, and ultimately used kelly clamps to pull the sutureless connector off. After disconnecting the catheter from the pump, there was no spontaneous retrograde flow of csf (cerebrospinal fluid). The hcp then removed the existing 27. 9 cm pump segment and trimmed off an additional 4. 4 cm from the existing spinal segment. After splicing on 45 cm of a new catheter and attaching the revised catheter to the new pump, the hcp was able to obtain csf from the cap (catheter access port)using a 24 guage non-coring needle. There were no environmental, external, or patient factors that may have led or contributed to the issue, and it was noted that the hcp did not suspect any issues with the therapy. No diagnostics/troubleshooting was done prior to surgery. After the procedure, the infusion rate of the new pump was decreased by 50% to 584 mcg/day and the patient was admitted overnight for observation for potential intrathecal baclofen overdose or withdrawal. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
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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 Key15101542
MDR Text Key296571771
Report Number3004209178-2022-09443
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
Remedial Action Notification
Type of Report Initial,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 07/26/2022 Patient Sequence Number: 1
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