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); Aspiration Issue (2883)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 8709, serial# (b)(4), implanted: (b)(4) 2009, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving baclofen dose and concentration not reported, via an implantable pump.The indications for use were intractable spasticity and cerebral palsy.It was reported that the patient was on a high intrathecal baclofen dose and the patient may be tighter per the patient¿s mother but clinically the healthcare provider stated that there were no symptom issue with the patient.The healthcare provider performed a cap (catheter access port) procedure and determined the catheter was not patent.It was unknown if there were any pump alarms or reservoir volume discrepancies.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received on 06-feb-2018 from a healthcare professional who reported that the cap (catheter access port) procedure was done on (b)(6) 2018.They were currently tapering down the pump with a plan to explant the pump.The cause of the catheter not being patent was reported to be ¿pending¿.No further complications were reported/anticipated.

Manufacturer Narrative

Additional concomitant medical products: product id: (b)(4); 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 professional (hcp) via a manufacturer representative.The patient was not getting the spasticity relief the physician expected.The dose was increased and it has not helped.No environmental/external/patient factors may have led or contributed to the issue.Surgical intervention was planned for (b)(6) 2018 to replace the catheter.Patient status was alive - no injury.The issue was not resolved.Patient weight and medical history was asked but unknown.The pump was delivering gablofen (unknown concentration and dose).

Manufacturer Narrative

The main component of the system and other applicable components are: product id 8709, serial# (b)(4), implanted: (b)(6) 2009, 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 reported that the pump was delivering gablofen (2000 mcg/ml at 899 mcg/day).The patient reported having an increase in spasticity.There were no environmental/external/patient factors reported that may have led or contributed to the issue.The catheter was explanted and replaced on (b)(6) 2018 and was going to be returned to the manufacturer.The issue was resolved at the time of the report.The patient's status at the time of the report was alive - no injury.It was noted that a catheter dye study was done on (b)(6) 2017, and the study was normal.No further complications were reported.

Manufacturer Narrative

The pump and catheter were returned for analysis.Analysis of the pump found ¿pump ¿ overinfusion ¿ undetermined root cause¿ and analysis of the catheter found ¿no significant anomalies¿.(b)(4).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: 7224111
• MDR Text Key: 98439435
• Report Number: 3004209178-2018-01495
• 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: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 01/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 02/06/2018; 04/10/2018; 04/17/2018; 06/14/2018
• Supplement Dates FDA Received: 02/07/2018; 04/12/2018; 04/19/2018; 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 69