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

Model Number 8637-40

Device Problems Kinked (1339); Obstruction of Flow (2423); Material Integrity Problem (2978)

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

Event Type  Injury  

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #:(b)(4), ubd: (b)(6) 2018, 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 via a company representative regarding a patient who was receiving a compounded baclofen with concentration 2000 mcg/ml at a dose rate of 1100 mcg/day and bupivacaine with concentration 20 mg/ml at a dose rate of 10.9 mg/ml via an implantable pump for intractable spasticity.It was reported that the patient experienced a return of spasticity.Diagnostic tests / troubleshooting performed in the operating room included a motor study and dye study.The rotor test showed the pump was fine; however, the pump segment of catheter showed a shear and after the anchor there was a kink.The event occurred during normal use.The date of event was unknown.The pump and complete catheter were explanted and replaced.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that the patient was very active.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.The patient¿s weight and medical history were noted as having been requested but were unknown.The company representative was in possession of the explanted device which was planned to be returned to the manufacturer.Other medications (oral, etc.) the patient was taking at the time of the event was unable to be obtained.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.Correction: the pump serial number was corrected from being (b)(4), and as a result the expiration date and implant date were corrected.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Due to imdrf harmonization, the previously applied device (b)(4) is no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a company representative.The pump rotor study was performed with no issue found and the dye study however showed no spread; catheter was broke at proximal end with shear and a kink was at the anchor site.The patient had recovered without sequela regarding their status after the device was removed.The device was returned to the manufacturer for analysis.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the catheter on (b)(6) 2018 revealed a hole in the catheter body caused by repeated flexing and also damage to transition tube.The conclusion code pertains to the analysis finding of a hole caused by repeated flexing.The conclusion code pertains to the analysis finding of damage to the catheter¿s transition tube.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: 7650352
• MDR Text Key: 112729037
• Report Number: 3004209178-2018-14646
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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