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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Therapeutic Response, Decreased (2271); Anxiety (2328); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/23/2020

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 manufacturing representative (rep) regarding a patient receiving an unknown medication via an implantable pump.However, it was indicated there were multiple medications compounded.It was reported that a motor stall occurred on (b)(6) 2020.The motor stall recovered and then stalled again.The patient had not had a magnetic resonance imaging procedure (mri).There were no known sources of magnetic/electromagnetic interactions.Motor stall considerations were reviewed.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

Product id neu_ptm_prog, serial# unknown.Product type programmer, patient.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2020-feb-26, additional information was received from the manufacturer representative (rep).Additional information reported the cause of the motor stall was unknown at this time.The rep reported a pump replacement was scheduled for (b)(6) 2020.This was later reported to be a replacement date of (b)(6) 2020.Per the "reps knowledge", the stall has not recovered.On (b)(6) 2020, the patient's husband called and stated the patient had a failed pump which caused the patient to not sleep or eat for 5 days.The caller added that with the failed pump, the patient had almost collapsed and the patient was having tremendous amount of angst and nervousness and the patient still cannot sleep very well.The caller stated that the patient had a new pump put in and the patient went to give herself a bolus last night and they received error code message of 8621 for wrong pump.The caller was redirected to their hcp to discuss therapy concerns and to have the ptm paired with the new pump.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on 2020-apr-15.It was confirmed that the explant date was (b)(6) 2020 and the patient's weight was provided.

Manufacturer Narrative

Correction: it was previously reported that the patient had a failed pump which caused the patient to not sleep or eat for 5 days.However, it was instead reported that the patient went 6 nights with no sleep and didn¿t eat due to withdrawal from the pump failure.

Event Description

Addition information was received via a consumer.The patient had experienced withdrawal from the pump failure.

Manufacturer Narrative

H1: corrected h3: analysis results were not available at the time of this report.A follow-up report will be sent once analysis is complete.H6: the evaluation codes have been updated for this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The pump was returned to the manufacturer for analysis.

Manufacturer Narrative

Interrogation of the device revealed the pump had been programmed to dispense 2.0 mg/ml of dilaudid and 5.0 mg/ml of bupivacaine.Analysis of implantable pump serial number (b)(6) revealed residue in the motor gear train and wearing on the lower shaft of gear number two.The evaluation codes have been updated for this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9751295
• MDR Text Key: 183770165
• Report Number: 3004209178-2020-04034
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 76