MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Energy Output Problem (1431); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 01/14/2020

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 implantable neurostimulator (ins) was nearing the end of its life and was at 2.69v.Yesterday, however, the patient felt a lot of "surging" and "swirling" where the leads/probes were so they checked their ins and the patient programmer (pp) showed it at 2.71v.They were wondering if this was possible/normal for the voltage to increase.On (b)(6) 2020, the patient called back and reiterated the issue, adding that when they felt the surge they "felt like" their "arms and legs were burning." experiencing "unexpected stimulation." the patient stated they were scheduled to get their current ins replaced because their battery "is going to deplete soon.".

Manufacturer Narrative

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

(b)(6) 2020 rtg snow rtg0004299 (con): it was reported that the patient's implantable neurostimulator (ins) was nearing the end of its life and was at 2.69v.Yesterday, however, the patient felt a lot of "surging" and "swirling" where the leads/probes were so they checked their ins and the patient programmer (pp) showed it at 2.71v.They were wondering if this was possible/normal for the voltage to increase.(b)(6) 2020 rtg snow rtg0005459 (con): the patient called back and reiterated the issue documented, adding that when they felt the surge they "felt like" their "arms and legs were burning." experiencing "unexpected stimulation." the patient stated they were scheduled to get their current ins replaced because their battery "is going to deplete soon." the patient wanted to know more information about whether they'd feel the surge of stimulation again and whether this would be detrimental to their health.Technical services were consulted and information was reviewed with the patient.They were redirected to follow-up with their hcp and manufacturing representative (rep) to check on the device.A rep paging number was provided to give the healthcare provider (hcp).The phone number for pss was provided for the hcp to call if they have questions.2020-feb-17 rtg0004299x2 (con): additional information was received: it was reported that the patient called back and reported that the eri message came up today and mentioned that the battery dropped down quickly.The patient had an appointment with their hcp on (b)(6) and also mentioned that today they were having an ekg and x-rays and wanted to know the guidelines, and how to turn off the ins.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9683088
• MDR Text Key: 178200031
• Report Number: 3004209178-2020-02845
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR