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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Blurred Vision (2137); Dizziness (2194); Complaint, Ill-Defined (2331); Sweating (2444); Shaking/Tremors (2515)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient receiving morphine(10.0 mg/ml, 0.800 mg/day) via an implantable infusion pump for the treatment of non-malignant pain.It was reported that the pump was not working on (b)(6) 2018 and had bad reactions.The medication had not relieved the pain since i mplant ((b)(6) 2018).On (b)(6) 2018, the pump was turning.It would flip like when he sat on the toilet.The patient had to flip the pump back in place when he got up from the toilet.The patient went in for a refill on (b)(6) 2018 and the healthcare provider had a hard time reading the pump.The patient started feeling terrible pain down the right leg 1 to 1.5 weeks after implant.The patient got dizzy on the night of (b)(6) 2018 and could not roll over.His vision was blur and he was sweating and shaking.No further complication was reported.

Manufacturer Narrative

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

Event Description

Additional information was received form the healthcare provider (hcp).Device was placed a little low, likely "initially the lateral formal cutaneous nerve after implant".The patient was stable at the time of the report and the reported symptoms might have been medication issue as the patient stopped his oral medication abruptly.Follow-up was fine with reading the pump.No further complication was reported.

• 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: 7396107
• MDR Text Key: 104689773
• Report Number: 3004209178-2018-06440
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2018
• Date Device Manufactured: 02/15/2018
• 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 Age: 78 YR