MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Material Integrity Problem (2978)

Patient Problems Muscular Rigidity (1968); Tachycardia (2095); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 01/09/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (2000 mcg/ml at 699 mcg/day) via an implantable pump for unknown indications for use.It was reported that the patient was in the hospital on (b)(6) 2022 due to increased tremors, tachycardia, increased sweating, and increased spasticity (symptoms consistent with baclofen withdrawal).Interrogation of the pump showed that the pump was working as it should be; however, ct scan/imaging showed that the spinal segment of the catheter was apparently coiled up in the low back region. there were no known factors that may have led or contributed to the issue. spinal segment of the catheter was replaced using a 8598a revision kit, re-inserted into the intrathecal space, and connected to the existing catheter.The issue was resolved at the time of report.The patient's medical history was asked and will not be made available.The patient's status at the time of report was alive - no injury.

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: , udi#: (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 NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13227710
• MDR Text Key: 284805808
• Report Number: 2182207-2022-00053
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2017
• 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: 01/09/2022
• Date Device Manufactured: 04/26/2016
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 97 KG