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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Dysphasia (2195); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported that caller reported pt had been in the hospital a couple of weeks ago and is now in a rehab facility.Caller reported prior to going to the rehab the patient had called medtronic about their recharging equipment and may have received replacement equipment but caller thinks pt still has a recharging issue because they are noticing pt has some neurological issues that they think may be related to the charging equipment not working, they were: "not right" they said they "felt muddled" and their speech was slurred.Caller said they will also call the patient's doctor about the symptoms.Caller said they were calling to confirm medtronic sent replacement equipment.See 705172340 and 704917408 for recent replacements.Additional information was received from hcp that they wanted to ensure they were using external equipment properly.Caller confirmed patient was currently charging first quartile of ins with 8 coupling boxes and ins was off.Tss reviewed general recharging information and how to use patient programmer to turn ins back on after reaching at least 25% charge.Tss faxed caller programmer and recharger quick guides.Additional information was received from a manufacturer's representative (rep) that patient is in the er.Rep is stating they are complaining that they got new recharging product and are saying they only had to charge 30-40 minutes in the past and now they are charging for 4-5 hours.The caller notes that the pt charges when ins is around 75% typically; tss reviewed at this battery level it is normal to charge 4-5 hours.The caller provided info from charge diary: 9-19 0-25% 1.5 hours excellent 9-19 25-50% 2.36 hours excellent 9-20 25-50% 42 minutes excellent 9-6 50% 14 minutes 9-2 75% 1.7 hours 8-30 75% 11 minutes.Tss advised these numbers appear fairly within reason.The purpose of the caller's call was to get a wireless recharger for the pt.Additional information was received from the manufacturer representative (rep) that the patient's hospitalization and rehab stay were not related to dbs device or therapy.The cause of the charging issue was patient difficulty using the recharger and not understanding the icons on the recharger.The patient was ordered a new wireless recharger.The charging issues and ins being off were resolved.This information was confirmed with the patient/account.

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 PARKINS
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15567186
• MDR Text Key: 306994299
• Report Number: 3004209178-2022-13081
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2022
• Date Device Manufactured: 11/25/2013
• 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
• Patient Age: 76 YR
• Patient Sex: Male