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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 Migration or Expulsion of Device (1395); Unstable (1667); Volume Accuracy Problem (1675); Material Integrity Problem (2978)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 08/24/2017
Event Type  Injury  
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter. 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 received from a consumer via a company representative regarding a patient receiving compounded baclofen 100mcg/ml at 50 mcg/day, prialt/zoconotide at 10mcg/ml at ¿5mcg¿ and bupivacaine 4mg/ml at ¿2mg/ml¿ via an implantable pump. The indication for use was non-malignant pain. The patient reported slow decline in therapy since the original implant. The patient stated that the pump moves freely in the pocket. The healthcare provider reported at the time of the refill on (b)(6) 2018 that a residual volume discrepancy of +3ml was noted. At the time of explant, there was no residual volume discrepancy. The actions and interventions taken to resolve the issue was both the pump and catheter were replaced as the catheter was found coiled inside the pump pocket. The issue was resolved at the time of the event and it was noted that the healthcare provider would not have any further information regarding the event. The patient status was noted as alive, no injury and no further complications were reported.
 
Manufacturer Narrative
The pump and catheter were returned for analysis. Analysis of the pump found ¿no anomaly¿. Analysis of the catheter found ¿catheter body - has significant twisting that may have affected infusion¿ and ¿catheter body ¿ damage to transition tube¿. Conclusion code (b)(4) is no longer applicable for the pump and is being replaced with conclusion code (b)(4). Conclusion code (b)(4) is no longer applicable for the catheter. The conclusion code for the analysis finding of ¿catheter body ¿ has significant twisting that may have affected infusion¿ is (b)(4). The conclusion code for the analysis finding of ¿catheter body ¿ damage to transition tube¿ is (b)(4). Corrected information - device code (b)(4) should have been included on the initial mdr. 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 Key7536237
MDR Text Key108981012
Report Number3004209178-2018-11598
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530119
UDI-Public00643169530119
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2017
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: 05/23/2018 Patient Sequence Number: 1
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