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

Model Number 37612

Device Problems Material Frayed (1262); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Shaking/Tremors (2515)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 37761, serial#: (b)(4), product type: recharger.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

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that the desktop charger had a frayed cord and the connector pin is bent and the connection is loose.The wire is frayed and they can seen the wires.The rep gave them a new desktop charger.Not sure where they got the desktop charger from but it had a bent pin.Told to get it replaced.They received the replacement desktop charger but the ins was when charging still did not have any coupling boxes.Additional information was received: it was reported that the patient called back to get clarification on shipping instructions to send back damaged equipment.The patient mentioned issues that had already been documented and shipping instructions were reviewed with the patient.The patient called back again for help on setting up the return of the shipment of the damaged equipment.The tracking number was confirmed with repair and item would be picked up.The patient mentioned the same issues in the crts again and included they thought it was too hard to get the ins to charge fast enough.It was reviewed the expected charging times, coupling bars, and confirmed equipment was working as intended.The patient mentioned their left arm was shaking bad, but the rest of the body was fine.The patient stated it had been happening for a couple weeks.Their setting was a low number on the right side and the left side could be up quite high.The patient was very hard to understand.Patient services offered troubleshooting, but the patient stated they were seeing their doctor next week.There were no further complications reported.

Manufacturer Narrative

Concomitant medical products: product id: 37761, serial# (b)(4), product type: recharger.Analysis confirmed that the patient's connector pin was damaged.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 37761 serial# (b)(6).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.

Event Description

Additional information was received: it was reported that the replacement of the patient¿s damaged connector pin didn¿t resolve the issues of charging and shaking in their left arm.The patient¿s right arm was shaking too and wasn¿t before.There wereno further c omplications reported.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id: 37761; lot# serial#: (b)(6); product type: recharger correction to show codes on ins.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.

• 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: 8857416
• MDR Text Key: 162810121
• Report Number: 3004209178-2019-14915
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/20/2019

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: 01/28/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/05/2019; 09/03/2019; 09/03/2019
• Supplement Dates FDA Received: 08/13/2019; 09/20/2019; 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 161