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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 Material Too Rigid or Stiff (1544); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 07/17/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine 20 mg/ml at 1. 698 mg/day via an implantable pump for an unknown indication for use. It was reported that during a refill on (b)(6) 2019, a volume discrepancy was detected. The expected drug volume was 15. 8 ml and the actual aspirated volume was 20ml. The patient experienced signs of withdrawal and more pain. It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. The diagnostics performed were the refill and a check of the actual vs. The expected volume. Surgical intervention was scheduled for (b)(6) 2019. The issue was not resolved at the time of the report and the patient status was alive-no injury. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Product id neu_unknown_cath lot# unknown serial# unknown implanted: explanted: (b)(6) 2019. Product type catheter. Product id neu_unknown_cath lot# unknown serial# unknown implanted: unknown explanted: (b)(6) 2019. Product type catheter. Device code (b)(4) captures the report of crystallized residues in the lumen of the second spinal segment of the catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that after opening the pump pocket the spinal catheter segment was severed. The physician checked if the second spinal segment is still intact and continuous but there was crystallized residues in the lumen. Therefore, the implanter decided the replace the entire catheter and the pump on (b)(6) 2019. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot# unknown, explanted: (b)(6) 2019, product type: catheter. Product id: 8780, lot# unknown, explanted: (b)(6) 2019, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot# 0215499707, serial#: n/a, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter. Product id: 8780, lot# 0215499707, serial#: n/a, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 8780, lot# 0215499707, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter; product id: 8780, lot# 0215499707, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter. Destructive analysis identified residue in the motor gear train. Analysis identified wearing on the lower shaft of the rotor. Visual inspection identified a break in the catheter. Analysis determined the collet was not fully locked into place. Visual inspection identified there was damage to the transition tubing. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 8780, lot# 0215499707, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter; product id: 8780, lot# 0215499707, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was previously reported that the daily dose of the morphine was 1. 698 mg/day and new information reported that the daily dose is 1. 65mg /day. It was previously reported that the implant date of the catheter was (b)(6) 2018 and additional information from the user report reported that the implant date was (b)(6) 2018. It was further reported that the crystallized residue in the catheter lumen was drug and led to an interruption of the drug distribution intrathecal, (no cerebrospinal fluid flow after disconnection of the catheter spinal, epifascial), the catheter which had become rigid due to the crystallization was torn abdominal subcutaneously in the pump pocket left (intraoperative photo documentation), the pump did not give a pump alarm despite increased flow resistance. Due to the inadequate pain therapy, the patient had to be switched to oral medication with mst 100, on (b)(6) 2019 an additional surgical intervention with complete exchange of the drug pump system became necessary, the morphine concentration was reduced to 10mg/ml. The patient's year of birth was (b)(6). No further complications were reported and/or anticipated.
 
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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 Key8811621
MDR Text Key151727271
Report Number3004209178-2019-13946
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2015
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: 07/22/2019 Patient Sequence Number: 1
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