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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 Pumping Stopped (1503); Obstruction of Flow (2423); Application Program Problem (2880); Communication or Transmission Problem (2896)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 10/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated the patient¿s weight was (b)(6) and the cause of telemetry and stopped pump was reported as ¿there could have been a glitch with the programmer. ¿ at this point, it felt the cause was undetermined. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
Concomitant medical products: product id: a810, serial#: unknown, product type: software. Other relevant device(s) are: product id: a810, serial/lot #: unknown. 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 (rep) regarding a patient receiving intrathecal clonidine 100 mcg/ml at 36. 2 mcg/day, bupivacaine 30 mg/ml at 10. 859 mg/day, and dilaudid 20 mg/ml at 7. 240 mg/day via an implanted pump for non-malignant pain. The patient had been complaining of increased pain for the past month and contacted their healthcare provider (hcp) a few days ago regarding this. The patient was brought in on (b)(6) 2018 where they had performed a pump refill and programmed a single bolus of 5 mg over 1 hour to see how well the patient responded. The caller updated the pump like normal, saw the ¿update complete¿ screen and tapped on okay and gave the patient their new refill date. The patient was in on the date of this report complaining of increase in pain and feeling like they never got their bolus. The patient¿s pump was also alarming. The caller was seeing the message that the pump had been stopped for over 50 hrs. The logs showed the critical alarm- stopped pump duration exceeded 48 hours on (b)(6) 2018. The report with the logs was reviewed with caller that it looked like the pump never got the complete programming update on (b)(6) 2018 which was why they were only seeing 5 programming steps instead of the usual 7 programming steps. The caller was the one who had updated the patient¿s pump and she remembered seeing the "update complete" message which was why she did not re-interrogate the pump to ensure all programming had gone through. She reported this was unsafe for their patient if the programmer did not let them know of a true complete update or not. It was reviewed the programmer should have given her a message if it was stopped and she confirmed she never saw a message saying this about the pump. The hcp had given the patient another bolus on the date of this report and updated the pump appropriately and confirmed the update went through. The patient was feeling better now and they would keep on monitoring the patient and their increase in pain symptoms and if needed, they will schedule a catheter dye study at a later date. The patient¿s increase in pain started about a month ago in 2018 and on (b)(6) 2018, the pump was in stopped mode since the update was not completed. The patient felt they never received the bolus and had an increase in pain. The clinician programmer did not show the message that the pump was stopped. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a company representative (rep) indicated in regard to which programmer was used to update the pump on 2018-sep-27 it was noted the a810 clinician programer app was used. No further complications were reported/anticipated or expected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer. It was reported that the patient experienced back spasms following the catheter being occluded. It was reported that there was a build-up of calcium in the catheter. The healthcare professional was able to break through some of the occlusion. The patient reportedly had still not fully recovered from the surgery in (b)(6) 2019. No further complications were anticipated/reported.
 
Manufacturer Narrative
Section 'device' refers to the main device other components include: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2019, product type: catheter; product id: a810, serial# unknown, product type: software; product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2019, product type: catheter. ¿analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. ¿ 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 2019-jan-22. It was reported that the issue was resolved. The serial numbers of the occluded catheter portions were provided. It was reported that the pump and catheter were returned for analysis.
 
Manufacturer Narrative
The pump was returned and analysis found wear on the motor o-ring for gear number three. Analysis identified use error associated with the event. The catheters were returned and no anomalies were noted on microscopic inspection, the catheters were patent, and passed pressure leak testing. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp) via a manufacturer's representative (rep) on 2019-jan-10. It was reported that the patient would have their pump and catheter replaced on (b)(6) 2019. The hcp reported that the patient was having intermittent return of pain symptoms. A dye study concluded that the catheter was occluded. No further complications were reported.
 
Manufacturer Narrative
Concomitant medical products: product id neu_unknown_cath lot# serial# unknown implanted: explanted: product type catheter b2: updated to reflect the information received on 2019-jan-10 b5: updated to reflect the information received on 2019-jan-10 h1: updated to reflect the information received on 2019-jan-10. (b)(4) to reflect the information received on 2019-jan-10. 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
MDR Report Key8089714
MDR Text Key128450264
Report Number3004209178-2018-25827
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 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/22/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/20/2018 Patient Sequence Number: 1
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