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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Tingling (2171); Cramp(s) (2193); Numbness (2415); Loss of consciousness (2418); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 09/28/2018

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 (hcp) via a clinical study on (b)(6) 2018 regarding a patient receiving hydromorphone and bupivacaine (doses and concentrations unknown) via an implanted infusion pump.The indication for use was malignant pain.It was reported that on (b)(6) 2018 the patient reported numbness and tingling along the left side of his body resulting in difficulty walking/standing and urinary retention.The patient was started on urecholine and the plan was to change the concentration of medications at the next refill.On (b)(6) 2018 the patient reported intermittent altered mental status and worsening numbness following personal therapy manager (ptm) activations.The pump was reprogrammed and bupivacaine was decreased, hydromorphone was increased, and baclofen was added.On (b)(6) 2018 the patient reported an episode of blacking out and becoming unresponsive after the previous visit.The patient was transferred to the emergency department (ed) and treated for dehydration.They were unsure at the hospital if the change in medication contributed to this.After reviewing the programmer report from the previous visit including the bridge bolus, the provider thought the change in concentration could have led to the decreased blood pressure and the episode and also the numbness, tingling, and altered mental status following ptm activations.The event resulted in an unscheduled clinic or office visit.The event was ongoing.The etiology indicated the event was related to the device or therapy and was not related to the implant procedure.The event was related to the drug bupivacaine with an increase in dose noted as a contributing factor it was further confirmed that the unresponsiveness, low blood pressure, and hospitalization were thought to be caused by the change in it medication concentration.No further complications were reported or anticipated.

Manufacturer Narrative

Evaluation conclusion code does not apply.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 8781, serial# (b)(4), implanted: (b)(6) 2018.Product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from an hcp via a clinical study on 2019-jan-28.It was reported that on (b)(6) 2018 the plan was to revise the catheter secondary to pain at the catheter site.The patient also reported pain in the left shoulder which he thought could be attributed to the catheter location.The patient also reported feeling either pain relief, full body numbness, or stomach cramps following ptm activations.For the side effects, the patient was instructed to only request two boluses close together, not three or four.On (b)(6) 2018 the patient reported constant numbness and tingling, feeling unsteady on his feet, and altered mental status.On (b)(6) 2018 the catheter tip was repositioned to c3 which also resolved the side effects the patient had previously reported.The event resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Additional information was received from an hcp via a clinical study on (b)(6) 2019-.It was reported that the pump was delivering dilaudid (0.5mg at 0.74978mg/day) and bupivacaine (7.1mg at 10.64682 mg/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: 8046517
• MDR Text Key: 126397499
• Report Number: 3004209178-2018-24865
• 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,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2019
• 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: 01/30/2019
• Date Device Manufactured: 04/20/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 67