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 Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Overdose (1988); Complaint, Ill-Defined (2331); Sedation (2368); Weight Changes (2607)

Event Date 02/23/2018

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 consumer regarding a patient receiving baclofen ("does" and concentration not reported) via an implantable pump.The indications for use were intractable spasticity and cerebral palsy.The patient¿s medical history included a cervical issue due to a car accident and cervical surgery.On 15-jan-2019 it was reported that the patient was in the hospital in (b)(6) 2018 because they thought the medication was too high of dose and sedating the patient.The patient was in the icu (intensive care unit) and they ¿adjusted the pump¿ from ¿1100 to something¿.Additional information was received on 17-jan-2019 from the healthcare provider who reported that the patient was not in the icu (intensive care unit) there and had no additional information on where they would have been in the icu.The healthcare provider further reported that the patient was seen on (b)(6) 2018 for blood, reported by the patient as "bleeding to death," coming from the incision site from the replacement surgery on (b)(6) 2018.The healthcare provider indicated that there was minimal blood at the incision site and no wound dehiscence.A follow-up by a nurse practitioner on (b)(6) 2018 indicated no bleeding at the incision site.A follow-up by a nurse practitioner on (b)(6) 2018 indicated the wound had not dehisced, that the wound looked good, and that they were cleared to undergo a cervical surgery that was stated unrelated to the patient¿s infusion system.The healthcare provider indicated that they had no additional information to report.Additional information was received from the patient¿s mother who reported that the patient was not in the icu (intensive care unit) in (b)(6) 2018 as initially reported but in (b)(6) 2018.Per the patient¿s mother, the patient was in the icu because of the sedation the drug was causing.No other interventions were performed, and the patient recovered.The patient then began having spasms about 30 days after the pump was turned down in (b)(6) 2018, since they had not turned it back up.The reporter stated that they were not sure if there was something wrong with the pump, but they may be getting a dye study.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer indicated the patient was having some issues and going back and forth.It was reported the patient has had spasms and the spasms were getting worse.The patient had lost weight as a result since implant in (b)(6) 2018.It was further reported the pump was turned up so high" a company representative (rep) came and adjusted his pump when the patient was in the icu and they said the pump may have been giving too much drug, so the rep came to turn pump down in (b)(6) 2019.The patient was asking about dosing of drug over a period of time.The caller was to follow-up with the healthcare provider (hcp).It was noted the change in therapy/symptoms was gradual.The event date was (b)(6) 2018.No further complications were reported or 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: 8261630
• MDR Text Key: 133560814
• Report Number: 3004209178-2019-01331
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2019
• Date Device Manufactured: 01/20/2018
• 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; Life Threatening
• Patient Age: 28 YR