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

Model Number 8637-20

Device Problem Failure to Interrogate (1332)

Patient Problems Bronchitis (1752); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump.It was reported they could not update the pump.It was noted therapy was stopped and they could not clear nor bypass to update pump.The rep reported error codes 102 (the pump is stopped due to either temporary stop configured or due to failed update) and error code 140 (previous update failed).It was noted they tried to interrogate with a few different programmers and could not bypass to update pump.The logs showed the pump was stopped for 65 hours and 47 minutes and was set to temporary stop.It was noted the pump was in shelf mode and they were replacing it with another pump.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

Additional information received on 2020-mar-03 determined that the information captured in manufacturer's report number 6000030-2020-00039 is from the same event.All follow up reports will be submitted under this report number.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Please note the aware date of this issue is 2020-feb-11 and not 2020-feb-13 as previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep) reported the date reported and incident took place on (b)(6) 2020.No further complications was reported.

Manufacturer Narrative

The pump was returned, and analysis found bit flip in ram memory of the pump hybrid.All previously reported method and result codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id a810.Product type software, product id a810.Product type software.This device issue is known and documented in the labeling per (b)(4) ¿ n¿vision clinician programmer with software synchromed ii infusion systems.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: a810, product type: software, product id a810, serial# unknown, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer reported that due to the pump error and ultimate replacement of the pump the patient showed classic signs of baclofen withdrawal.The patient also developed bronchitis and stayed in the hospital for 5 days.The recovery was hard but the patient was doing ok and had an upcoming appointment (no date given) with the hcp to see what they do about the patient's stiffness.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9771916
• MDR Text Key: 182141437
• Report Number: 3004209178-2020-04351
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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): Required Intervention