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

Model Number 8637-40

Device Problems Kinked (1339); Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Anxiety (2328)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

References the main component of the device system; the other relevant components include: product id 8709, serial# (b)(4), implanted: (b)(6) 2012, product type catheter.

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving dilaudid (2.0 mg/ml at 0.8798 mcg/day), bupivacaine (10.0 mg/ml at 4.399 mg/day), and compounded baclofen (100.0 mcg/ml at 43.99 mcg/day) via an implanted pump.The indication for use was non-malignant pain.It was reported the patient experienced withdrawal symptoms, including worsening anxiety and increased pain on (b)(6) 2017.The clinical diagnosis was it opioid withdrawal and decreased therapeutic relief.The device diagnosis was catheter kink.The device was interrogated and a volume discrepancy was noted in which the estimated reservoir volume was 9.7 ml and the actual reservoir volume was 16.8 ml.The hcp attempted to aspirate the catheter was but unable to aspirate the medication from the catheter.It was noted the volume discrepancy and unable to aspirate the catheter were indicative of a catheter kink.Surgical observation was performed on (b)(6) 2017 and a catheter kink at the 2 o'clock suture loop was noted.It was indicated the event was related to the device or therapy.On (b)(6) 2017, the catheter was spliced and the pump segment was replaced.The issue resolved without sequelae on (b)(6) 2017.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The cause of the inability to aspirate the catheter and the volume discrepancy was noted to be due to the catheter kink.The patient's weight was (b)(6).No further complications were reported/anticipated.

Manufacturer Narrative

Additional review determined that the previously reported information pertaining to manufacturer's report # 3004209178-2018-01154 [volume discrepancy, catheter kink] was previously reported.Additional information regarding that event will now be reported under manufacturing #3004209178-2017-26718 [catheter kink].If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the drugs the patient was receiving at the time of the event was dilaudid (2.0 mg/ml at 0.8802 mg/day), bupivacaine (10.0 mg/ml at 4.401 mg/day) and compounded baclofen (100.0 mcg/mlat 44.01 mcg/day).

• 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: 7211233
• MDR Text Key: 97943009
• Report Number: 3004209178-2018-01154
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• 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: 02/07/2018
• Date Device Manufactured: 08/29/2017
• 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: 76 YR
• Patient Weight: 87