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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problems Shaking/Tremors (2515); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 37761, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implant wasn't charging.The only message that showed on recharger was "recharge recharger now" when the recharger was plugged into the desktop charger (dtc).The patient programmer (pp) showed "charge neurostimulator battery now" message.It was reviewed this means therapy is currently off.The patient started having a return of shaking this morning.During the call, it was discovered that the connector pin on the dtc was bent and the inside of the recharger port was damaged.This was why the recharger battery wasn't charging.It was explained that the recharger battery was too depleted to be used to charge the implant battery back up.The patient mentioned unrelated medical history including that the patient has cancer and had a medical procedure called chemo embolization.With everything going on, they had neglected to charge the implant battery for a while and it was just today that it was noticed that the patient wasn't able to charge the implant.

Event Description

Additional information was received from the consumer reporting they were able to charge and turn implant on with the replacement desktop charger and recharger.The return of shaking has resolved.

Manufacturer Narrative

Continuation of d10: product id 37761 lot# serial# (b)(6).Implanted: explanted: product type recharger product id 37651 lot# serial# (b)(6).Implanted: explanted: product type recharger 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 12512575
• MDR Text Key: 272686903
• Report Number: 3004209178-2021-14227
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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: 09/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/08/2021
• Date Device Manufactured: 10/24/2014
• 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
• Treatment: "SEE H10...."
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 127 KG