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

Model Number 8637-40

Device Problems Disconnection (1171); Volume Accuracy Problem (1675)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8780, serial# (b)(4), product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 06-aug-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider (hcp) regarding an implantable intrathecal pump intended to deliver gablofen [2000 mcg/ml] at 2002 mcg/day, indicated for intractable spasticity.It was reported that the patient has had some increased spasticity and the caller was requesting general troubleshooting information.The event date was asked, but unknown.It was stated that at a refill in (b)(6) 2018, the expected reservoir volume (erv) was 3.9 ml and the actual reservoir volume (arv) was 6 ml.The caller did not have the refill volumes for (b)(6) 2018.As a result of the call, the caller was to discuss further with the physician and also contact the local manufacturer¿s representative to be available for the catheter access port (cap) dye study.No further complications were reported or anticipated.Additional information was received from a healthcare provider on (b)(6) 2018.It was stated that the event is unchanged, and plans are to do a catheter access port (cap) dye study.The caller requested coding information regarding billing of the cap dye study , and was redirected to the therapy access group.No further complications were reported or anticipated.Additional information was received from a healthcare provider (hcp) on (b)(6) 2018.It was reported that it appears the patient's pump catheter may not be attached to his pump.The cause of the volume discrepancy in (b)(6) 2018 was not determined.The hcp inquired if a 2.1 ml difference was something to worry about, and if the catheter not being attached to the pump could explain the discrepancy.It was indicated that the cause of the increased spasticity had not been determined, but that the hcp thought it was because the catheter is not attached.It was reported that a ua (urine analysis) and an x-ray were performed as diagnostics related to theincreased spasticity.The hcp noted that the pumps are often off by 2 ml, sometimes more, suggesting that they did not consider these volume discrepancies abnormal.It was reported that they would need to send the patient to a surgeon for the catheter issue.It was indicated that the issues had not yet been resolved.No further complications were reported or anticipated.Additional information was received from a healthcare provider on (b)(6) 2018.It was stated that the patent was having a cap dye study done the day of the report.Information was discussed related to the procedure and post-procedure priming bolus.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 from a healthcare provider (hcp) on 2018-may-04.It was reported that it appears the patient's pump catheter may not be attached to his pump.The cause of the volume discrepancy in (b)(6) 2018 was not determined.The hcp inquired if a 2.1 ml difference was something to worry about, and if the catheter not being attached to the pump could explain the discrepancy.It was indicated that the cause of the increased spasticity had not been determined, but that the hcp thought it was because the catheter is not attached.It was reported that a ua (urine analysis) and an x-ray were performed as diagnostics related to the increased spasticity.The hcp noted that the pumps are often off by 2 ml, sometimes more, suggesting they did not consider these volume discrepancies abnormal.It was reported that they would need to send the patient to a surgeon for the catheter issue.It was indicated that the issues had not yet been resolved.No further complications were reported or anticipated.(b)(6)2018 crts 3695628 update (hcp): additional information was received from a healthcare provider on (b)(6) 2018.It was stated that the patient was having a cap dye study done the day of the report.Information was discussed related to the procedure and post-procedure priming bolus.No further complications were reported or anticipated.(b)(6)2018 lfc1 (hcp): additional information was received from a healthcare provider (hcp) on 2018-may-22.It was reported that the results of the cap dye study performed on (b)(6) 2018-may-10 were inconclusive.They were unable to visualize the contrast under live fluoroscopy or by x-rays taken while injecting contrast.It was reported that the patient had been referred for surgery, and to confer with neurosurgery for further details.The patient's weight at the time of the event was unknown.No further complications were reported.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter.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 device manufacturer representative.It was noted that the pump was infusing baclofen (2000 mcg/ml at a dosage of 1711.9).The patient's medical history included diabetes.It was reported that the therapy was working, but not great.There were no environmental/external/patient factors that may have led or contributed to the issue.Per the healthcare provider (hcp), a study was done, and the pump was fine.The catheter did not really show anything.The catheter was aspirated and appeared to be working, but the hcp said that he wanted to replace it.The catheter was replaced.The issue was resolved at the time of the report.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

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

• 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: 7507773
• MDR Text Key: 108035523
• Report Number: 3004209178-2018-10713
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 05/22/2018; 06/08/2018; 06/13/2018
• Supplement Dates FDA Received: 05/25/2018; 06/08/2018; 06/18/2018
• Date Device Manufactured: 04/18/2017
• 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 Outcome(s): Required Intervention
• Patient Weight: 154