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

Model Number B35200

Device Problems Break (1069); High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)

Patient Problems Electric Shock (2554); Paresthesia (4421)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient's amplitude is set to 2.6 when he is standing, but when he sits or lies down he has to decrease it "2 notches" because he feels a tingling in his feet.The patient (pt) first noticed this when the implanted neurostimulator (ins) was turned on for the first time 3 days ago.Patient services redirected caller to pt's managing provide to have ins checked.Caller also mentioned that the amplitude was at 2.0 when the ins was first turned on and now it is at 2.6.Caller asked if the pt should continue increasing the amplitude.Patient services again redirected caller to pt's provider for guidance.Additional information was received from a healthcare provider (hcp) via a manufacturer representative (rep) reporting that the patient is complaining of shocking sensations that are worsening and occurring only when he is laying down (back, stomach, and jaw).Previously, he was having tingling in his lower left extremity that went away when the device was turned off in office with the provider in (b)(6) 2020.Last impedance check showed: impedance check at 1.0 ma - r gpi monopolar impedance at 1.0 ma 11 - 614 10 - 1400 last time --> >5000 9 - 1027 8 - 1411 r gpi bipolar impedance at 1.0 ma 11 1860 1448 >10k 10 >10k >10k 9 1747 l gpi 3 - 726 2 - 1355 1 - 985 0 ¿ 1376 the issue was not resolve.It is unknown if surgical intervention is planned.The rep will contact the patient for further information.

Manufacturer Narrative

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

Manufacturer Narrative

Other relevant device(s) are: product id: 3387s-40, lot#: va282cs, implanted: (b)(6) 2020, product type: lead.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.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the patient was going to be in the office on (b)(6) for a system check.The patient turned their system off and the shocking subsided.The rep mentioned the patient told them they fell ¿all the time¿ so it was suspected there was a fracture in the system.At the current time no surgical intervention was planned.

• Brand Name: PERCEPT
• 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 00777
• MDR Report Key: 12662566
• MDR Text Key: 277365139
• Report Number: 3004209178-2021-15579
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR