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 Fall (1848); Dizziness (2194); Cognitive Changes (2551); No Code Available (3191)

Event Date 06/13/2017

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 regarding a patient receiving hydromorphone at an unknown concentration and dose via an implantable infusion pump.It was reported the patient reported dizziness and lightheadedness on (b)(6).The intrathecal rate was decreased in an effort to alleviate the symptoms.The patient was instructed to sit for 15-20 minutes following activating the personal therapy manager (ptm) to help prevent the dizziness and lightheadedness following ptm activations.The clinical diagnosis was intrathecal medication side effects.The outcome was ongoing.The etiology of the event was noted as related to the device or therapy and related to the drug hydromorphone with the drug action that caused the event being therapy initiation.Additional information received from a healthcare provider (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(6).Interventions included the pump was reprogrammed on (b)(6).On (b)(6), the patient reported hallucinations and episodes of falling.On (b)(6) the patient reported dry mouth following personal therapy manager (ptm) activations.The intrathecal rate was decreased on (b)(6).The correct serial number was provided.Indication for use was spinal pain.No further complications were reported/anticipated.

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 patient was receiving hydromorphone (0.5 mg/ml at 0.49981 mg/day) and bupivacaine (7.1 mg/ml at 7.0872 mg/day) via an implantable pump.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare provider (hcp) via clinical study indicated the cause of the hallucinations, light headedness, dizziness, dry mouth, and episodes of falling was due to therapy initiation.It was noted that the symptoms resolved with reprogramming.The patient's weight was not measured.No further complications were 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: 6989153
• MDR Text Key: 90626326
• Report Number: 3004209178-2017-22806
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 11/14/2017; 12/11/2017
• Supplement Dates FDA Received: 11/17/2017; 12/11/2017
• Date Device Manufactured: 04/06/2017
• 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): Other
• Patient Age: 70 YR