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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Migration or Expulsion of Device (1395); Unstable (1667); Obstruction of Flow (2423); Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving hydromorphone (6.0 mg/ml at 0.7509 mg/day), compounded baclofen (450.0 mcg/ml at 56.32 mcg/day), and bupivacaine (25.0 mg/ml at 3.129 mg/day) via an implanted pump.The indication for use was non-malignant pain.It was reported the patient had difficulty connecting the personal therapy manager, ptm, and pump secondary to the pump flipping on (b)(6) 2018.The device diagnosis was other difficulty activating ptm and the clinical diagnosis was worsening pain.The patient noted worsening pain, as they were unable to administer a bolus.It was indicated the event was related to the device or therapy.The patient's pump was reprogrammed and the it rate was increased on (b)(6) 2018.The patient's pump pocket will be revised following cardiac surgery and subsequent clearance.The event was noted as ongoing.

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 during a pump refill, on (b)(6)2017, it was noted a ultrasound guidance was utilized during the refill to minimize risk, as the pump had been flipped.The device diagnosis was pump inversion.The plan was to revise the pump pocket but the revision was cancelled, on (b)(6)2018, secondary to cardiac issues.It was indicated the event was related to the device or therapy.On (b)(6)2018, the revision surgery was postpones until cleared but cardiologist, as patient requires cardiac surgery.It was noted the pump was not entirely flipped and the revision was not emergent.No actions were taken and the issue was ongoing.

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 cause of the pump flipping was not determined.The patient's baseline weight was (b)(6) lbs.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) via a clinical study indicated it was unknown if the explanted segment of the catheter and connecting pins will be returned.No further complications were reported/anticipated.

Manufacturer Narrative

(b)(4).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 that on (b)(6) 2019, the patient denied difficulty activating the ptm without intervention.The issue resolved without sequelae on that date.

Manufacturer Narrative

Product id: 8781, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp) via clinical study indicated the outcome of the event resolved without sequelae on (b)(6) 2019.It was noted the pump was repositioned where it was re-anchored in the pocket.On (b)(6) 2019, during a surgical revision of the pump, catheter kinks were noted at the connector at the pump and at the nose of the anchor.Surgical intervention occurred where the catheter was spliced, replacing the pump segment and the connecting pin was replaced.No further compilations were reported/anticipated.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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 cardiologist did not clear the patient for surgery on (b)(6) 2018.The patient was provided with oral baclofen should an emergent situation arise.The event was unresolved at time of study exit/death/study closure.Additional information received from a healthcare provider via a clinical study reported the outcome of this event was ongoing as of (b)(6) 2018.The subject had not been exited from the study.

• 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
• MDR Report Key: 7464953
• MDR Text Key: 106625920
• Report Number: 3004209178-2018-09353
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 55