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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 8637-40
Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 07/29/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2017, product type catheter; 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 company representative (rep) regarding a patient receiving intrathecal fentanyl 666 mcg/ml at 99. 4 mcg/day, hydromorphone 6. 7 mg/ml at 0. 99 mg/day, and bupivacaine 20 mg/ml at 2. 98 mg/day via an implanted pump for non-malignant pain. A volume discrepancy was reported and the actual residual volume was 28 milliliters (mls) and the expected residual volume (erv) was 6. 8 mls on (b)(6) 2018. It was noted there were no discrepancies noted on past refill. The patient experienced increased pain on (b)(6) 2018 and the change in symptoms/therapy was sudden. It was unknown what the reservoir volume injected at the last refill was. Prior to the call troubleshooting included accessing the reservoir and a dye study was done. It was also noted this was not the first refill after implant/revision. It was reported when they tried to perform a dye study due to volume discrepancies on the date of this report, it failed. The ascenda catheter was ¿kinking¿ so they could not complete the dye study. 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
It was indicated a catheter revision occurred.
 
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 manufacturer representative on (b)(4) 2018. It was indicated that the hcp's nurse initially reported the event. An image confirming the catheter kink was provided, and a video documenting the dye study was provided. The video indicated that at first nothing was coming out, and then the hcp stated "maybe a little bit, but really not free-flowing. " the hcp pressed on the patient's abdomen and indicated he was going to retract, and as he pulled back the syringe slightly, fluid could be visualized flowing through the tubing. It was noted that "this is how it should be. ".
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation of implantable catheter serial number (b)(4) revealed the following. The partial catheter was returned in one segment with the anchor attached and comprised the distal region of the catheter. Analysis identified a kink in the body of the catheter. Analysis also identified a compressed area on the body of the catheter approximately 43 cm from the distal end. The compressed area was abraded, and a tear was identified in the catheter at the site of the abrasion. Leaking was observed from the tear during pressure leak testing in the lab. The evaluation codes have been updated. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The catheter was returned for analysis.
 
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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 Key7747493
MDR Text Key116724415
Report Number3004209178-2018-17373
Device Sequence Number0
Product Code LKK
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2017
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: 08/03/2018 Patient Sequence Number: 1
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