MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35300R

Device Problems Failure to Deliver Energy (1211); Overheating of Device (1437); Failure to Power Up (1476); Charging Problem (2892)

Patient Problems Confusion/ Disorientation (2553); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745, serial# unknown, product type: programmer, patient.Other relevant device(s) are: product id: 97745, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was having issues with charging their patient programmer and thought they stimulation had turned off and had a loss of therapy because of it.They tried charging it the night before but it wouldn't charge despite trying to connect to a different outlet.They thought the problem could have been the charger that plugged to the power outlet as there was a blinking green light they hadn't seen before.The patient programmer battery said it was low and they couldn't charge their ins.They would try changing their patient programmer batteries but it hadn't always worked in the past.Additional information was received: it was reported that the patient's mother confirmed stimulation was off and the patient wasn't doing well.There was also a photo of the patient's recharger showing that part of the plastic was melted.The patient said the recharger got hot when they disconnected it from the wall.

Manufacturer Narrative

Continuation of d10: product id 97745 lot# serial# (b)(6) implanted: explanted: product type programmer, patient.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

Additional information was received: it was reported that the patient used the battery and charging cord provided by the facility from a previous ptm and they were able to charge their device, turn it on, and resume therapy.A new product was then issued to the patient and the issue was resolved.

Manufacturer Narrative

Continuation of d10: product id: 97745, serial# (b)(6), product type: programmer, patient.H3: analysis of the ptm had shown that it had a bad lcd screen, the stimulation button was broken, case screws were stripped and had a cracked connector support where the ac power connects.It also tested ok on the bench with rtm and battery, but was unable to put on tester unless firmware was rewritten to 3.0.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: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13122342
• MDR Text Key: 286590748
• Report Number: 2182207-2021-02254
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: B35300R
• Device Catalogue Number: B35300R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/06/2022; 04/03/2023
• Supplement Dates FDA Received: 01/10/2022; 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2019
• 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