MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Charging Problem (2892)

Patient Problems Pain (1994); Discomfort (2330); Neck Stiffness (2434); Shaking/Tremors (2515); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id 37642 lot# serial# unknown implanted: explanted: product type programmer, patient product id 37751 lot# serial# unknown implanted: explanted: product type recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer who reported for the last month they had been gradually feeling symptoms of cervical dystonia as their neck and head starting pulling which caused soreness in their head.The patient also noticed their implantable neurostimulator (ins) battery level seemed to ¿not go down as much.¿ the patient last charged on sunday, but when they checked the ins batter level 4 days later the battery level was still at 100%.It was confirmed the ins was turned on and the therapy settings had not been changed.Current therapy settings were 2.80 c 3.60.There were no recent falls.During the call the patient programmer (pp) was used to check the ins and it showed the ins was off.During the call the patient turned the ins on and felt stimulation.The patient was advised to monitor their symptoms and follow-up with their healthcare provider (hcp) as necessary.Shortly after the patient turned therapy back on, they called back stating they were ¿seeing stars, shaking, convulsing, and wanted to turn therapy off.The patient was walked through turning therapy off and felt better.The patient was going to discuss this with their hcp.

Event Description

The patient said they dont know how the ins turned off.They have an appointment on (b)(6) for troubleshooting.They said their head/neck was pulling very hard causing pain.

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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11983737
• MDR Text Key: 255673839
• Report Number: 3004209178-2021-09242
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: 08/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR