MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

Patient Problems Headache (1880); Pain (1994); Anxiety (2328); Discomfort (2330); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# unknown, product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient reported that they could feel their ins turn off this morning, and when the checked their recharger they saw an informational por.The patient was redirected to their healthcare provider to clear the por and turn therapy back on if they are unable to find their patient programmer.No symptoms were reported.

Event Description

Additional information was received from the consumer who reported they were ¿up all night¿ because they were anxious or experiencing sleeplessness in anticipation of turning their implant back on.The consumer further reported their device had been overdischarged, but they weren¿t sure why the recharger showed the por message, but was able to clear the por message and turned therapy on about 6 hours ago.The consumer stated it ¿hurt like a dickens after turning therapy on¿ as they got a headache and some discomfort in their chest because ¿it hurt the battery pack¿ and all the juice went to the patient¿s brain.The consumer also felt hyper, especially hyperactive talking which is now how they talked before the device was turned back on (which was a good thing).When the consumer checked the ins charge level with the recharger it was about 25% charged and they now had it 100% charged.Unrelated overdischarge event captured in pe (b)(4).

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.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11678863
• MDR Text Key: 248229849
• Report Number: 3004209178-2021-06158
• Device Sequence Number: 1
• Product Code: MHY
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 94