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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 Filling Problem (1233); Migration or Expulsion of Device (1395); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Communication or Transmission Problem (2896); Material Integrity Problem (2978)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
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 consumer via a company representative regarding a patient receiving morphine 5mg/ml, dose not reported via an implantable pump. The indications for use was spinal pain. On (b)(6) 2018 it was reported the pump flipped. The healthcare provider was unable to complete the refill. The patient also stated difficulty getting the ptm (personal therapy manager) to communicate with the flipped pump but was eventually able to get it to work. It was noted that the earliest surgical intervention would be several days past low reservoir alarm date. The patient was brought back today, and the pump was manually manipulated and was then successfully filled. Morphine 6. 1ml was expected to be withdrawn from the pump, however 16ml was removed indicating a possible catheter occlusion. The pump logs were read, and no motor stalls were indicated. A catheter dye studywas planned with possible replacement. The environmental, external or patient factors that may have led or contributed to the issue was noted as the patient has had no falls or traumatic injury and has maintained current weight since implant. The actions and interventions taken to resolve the issue surgery was planned but not yet scheduled. The issue was not 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¿s status was noted as alive, no injury and no further complications were reported.
 
Manufacturer Narrative
Product id 8780 lot# (b)(4)implanted:(b)(6)2017 explanted: product type catheter product id 8780 lot# (b)(4) implanted: (b)(6)2017 explanted: product type catheter. Other relevant device(s) are: product id: 8780c , (b)(4), (b)(4) other relevant device(s) are: product id: 8780 ,(b)(4)(b)(4) ,(b)(4) if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 27-jun-2018 from a healthcare professional via a company representative who reported that a pump dye rotor study was attempted on (b)(6)2018, but under x-ray the catheter was visualized wrapped around the pump and the physician did not want to tryto access the catheter access port with the possibility that the access needle would damage the catheter. The pump dye rotor study was then cancelled. The patient was going to be scheduled for revision surgery. No further complications were reported/anticipated.
 
Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated: patient code (b)(4) no longer applicable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer who reported that the neurosurgeon told the patient the pump was only working at 20% due to the issues with flipping. The neurosurgeon had to ¿un-flip¿ the pump in (b)(6). The patient stated she has lost total control of her pain and cannot get it back. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 08-nov-2018 from a healthcare professional who reported that during the procedure in (b)(6), the pump pocket was revised; the pump was sutured; and the catheter was untangled. The pump was not explanted. After the revision, the patient¿s pump dose was reduced for safety and was the cause for the patient¿s pain after the revision. The dose was titrated to resolve the patient¿s pain. No further complications were reported/anticipated.
 
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter; product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a patient. The patient reported the pump was only working at 20% because the catheter was so kinked. No further complications were anticipated/reported.
 
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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
MDR Report Key7595973
MDR Text Key110879361
Report Number3004209178-2018-13284
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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