MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problems Fatigue (1849); Therapeutic Effects, Unexpected (2099); Dizziness (2194); No Code Available (3191)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8709, serial# (b)(4), implanted: (b)(6) 2003, product type: catheter; ubd: (b)(6) 2005, udi#: (b)(4).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 manufacturing representative (rep) regarding a patient receiving 25mg/ml of morphine at 17 mg/day via an implantable pump for non-malignant pain.It was reported there had been higher than expected residual volumes in the pump.It was unknown if there had been any environmental /external/patient factors that may have led or contributed to the issue.It was reported ¿catheter study done and drug picked through to try to clear possible occlusion.¿ the date of the event was provided as (b)(6) 2018.The physician planned to wait to see if the patient received relief.It was unknown if the issue had been resolved at the time of the report.It was unknown if surgical intervention had occurred.The patient¿s status at the time of the report was provided as ¿alive-no injury.¿ no further complications were reported or anticipated.Other medication being taken at the time of the event, patient weight, and medical history were unknown.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative (rep) (b)(6) 2018.The rep clarified that the report should have said "catheter dye study done and drug pushed through the catheter." it was reported the patient had experienced slight light headedness.It was indicated the volume discrepancies began a few months earlier.The expected residual volume vs.The actual residual volume was not known.It was indicated no further actions have been taken or planned.The physician was still waiting to see if the occlusion was cleared by pushing saline through the catheter.It was unknown if the patient had received relief yet.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp) (b)(6)2018.It was reported the volume discrepancy had occurred on (b)(6)2018.The expected residual volume (erv) was 6.1 milliliters (mls) and the actual residual volume (arv) was 11.0 mls.It was reported a pump study was performed (b)(6)2018.The preoperative diagnosis was provided as "mechanical complications of intrathecal pump." the postoperative diagnosis was also provided as "mechanical complications of intrathecal pump." it was reported the "contrast was injected to the pump, which had high resistance, but there was a noticeable give away and then contrast injected easily." the patient's weight was provided as (b)(6) and fluoroscopy had limited penetration.The physician studied the length of the catheter and the spinal fluid at the tip.The physician stated, "it was difficult determine whether contrast was coming out of the tip whether there was a myelogram.I injected a total of 6 ml of contrast thus was endowed." the physician then injected 20 ml of normal saline.The physician then tapped the pocket with an 18-gauge needle after maintaining sterile prep.No fluid could be obtained.The physician injected another 6 ml of contrast and another 5 ml of saline.The patient became noticeably drowsy and the pupils would not pinpoint.The physician stated the residual on the catheter would have given him a 5.4 mg bolus of marcaine and 250 mcg of fentanyl and suggested that the catheter was intact delivering that bolus.The physician was also able to "easily aspirate out the catheter with 10 ml of clear fluid suggesting the catheter and the spinal fluid even though contrast could not be identified clearly due to his body mass." the pump was programmed to fill the dead space in the catheter.The physician concluded the catheter and pump were still intact.It was reported the patient's previously reported symptoms had resolved.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 7469824
• MDR Text Key: 106866967
• Report Number: 3004209178-2018-09519
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Date Device Manufactured: 09/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 73