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

Model Number 8637-20

Device Problem Decrease in Pressure (1490)

Patient Problems Headache (1880); Malaise (2359); Low Oxygen Saturation (2477)

Event Date 04/08/2019

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 healthcare professional (hcp) regarding a patient receiving baclofen via an implanted pump.The indication for pump use was head/brain injury and intractable spasticity.On (b)(6) 2019 the hcp reported that the patient represented to the ed (emergency department) with symptoms consistent with altitude sickness, but because the patient had an intrathecal baclofen pump and the patient¿s pump managing physician told the patient that altitude could potentially affect the pump, the patient wanted the pump checked.The patient was at an altitude near 9,000 feet.The reporting hcp was asking for more details about the effects of altitude on the pump and checking the pump.Per the reporting hcp, the patient was due to return home tomorrow and he did not think they would be equipped to treat the patient¿s pump at their facility.If the patient didn¿t have the pump, the reporting hcp would have diagnosed the symptoms as altitude sickness.The patient had a headache, low o2 sats, and just wasn¿t feeling well.The symptoms had come on suddenly.No interventions were mentioned.The reporting hcp was going to attempt to reach the patient¿s pump managing physician in the patient¿s home state to decide how to proceed.No further complications have been reported as a result of this event.

• 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: 8498732
• MDR Text Key: 141452903
• Report Number: 3004209178-2019-07055
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• Date Device Manufactured: 09/03/2014
• 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: 40 YR