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

Model Number 8637-40

Device Problems Device Or Device Fragments Location Unknown (2590); Aspiration Issue (2883); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer¿s representative (rep) regarding a drug infusion device.The drug being delivered was 2,000 mcg/ml lioresal (baclofen) at 600 mcg/day.The reason for use was not reported.It was reported that the patient¿s mother complained that the system was not working.The rep was not able to determine when the problems first began.The mother said ¿months.¿ the doctor also said that they were unable to aspirate through the catheter access port (cap), but couldn¿t specify when that occurred.During surgery, they were unable to see any liquid in the 8709 connector.A pump roller study was performed to confirm that the pump was functioning normally.They were able to agree that the study proved that the rollers function normally, and no motor stalls were discovered in the logs.The pump connector was removed, a majority of the catheter was removed and a portion remains in the body.It was torn when the surgeon pulled it out.The rep estimated about 30 cm remains in the body.The customer was notified that the product was to be returned to the manufacturer but it would not be returned as it was discarded.The product was replaced by a 8780 ascenda product of the same manufacturer and the existing pump was reconnected to the new catheter which proved to be patent.There were no environmental/external/patient factors that may have led or contributed to the issue.The issue was resolved at the time of the report.All information was confirmed with the healthcare professional (hcp) and they had no further information on this event.There were no symptoms reported.There were no further complications reported/anticipated.

• 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: 7513967
• MDR Text Key: 108242621
• Report Number: 3004209178-2018-10894
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2018
• Date Device Manufactured: 11/17/2017
• 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 Age: 18 YR
• Patient Weight: 47