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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Infusion or Flow Problem (2964)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer¿s representative (rep) on 2018-jun-20. It was reported that it was unknown if further diagnostics/troubleshooting was performed, it was unknown what actions/interventions were taken to resolve the issues, it was unknown if the issue had been resolved, and the patient¿s weight was unknown. It was reported that serous fluid was not confirmed. The cause of the volume discrepancy and inability to aspirate was not determined. The current status of the device was ¿in use. ¿ the information was confirmed with the physician. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2011, product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), (b)(6), (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 who was receiving hydromorphone with concentration 18 mg/ml at a dose rate of 10. 4 mg/day and bupivacaine with concentration 11 mg/ml at an unknown dose rate via an implantable pump for non-malignant pain and chronic low back pain. It was reported that at the last pump refill in (b)(6) 2018 (month and year specified only) a reservoir volume discrepancy occurred; 16 ml was the actual residual volume and the expected residual volume was 2 ml. There was no withdrawal symptom, but the patient experienced increased pain. The date of the increased pain was unknown. Regarding the reservoir volume discrepancy, it was indicated that the physician thought the practitioner maybe aspirated serous fluid instead of drug via the reservoir and that the patient would have had withdrawals without the intrathecal dose. The company representative did not think the patient had any other prescribed medications to take if they were not receiving the intrathecal medications. The company representative noted there was nothing reported for a possible pocket fill and no overdose symptom that the company representative was aware of. The company representative had utilized a clinician programmer on (b)(6) 2018. It was further reported that the healthcare provider (hcp) was unable to aspirate the catheter access port (cap), not measurable aspirate per the reporter, for a catheter dye study to confirm catheter patency. They tried utilizing 3 cc and 10 cc syringes and were still not successful with the aspiration, so a roller study was performed. The roller study was successful. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
This field was corrected to include adverse event and product problem (previously product problem only. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 Key7620968
MDR Text Key112358207
Report Number3004209178-2018-13899
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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