MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

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 an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported there was poor coupling bars when charging the implant.It was never easy getting all coupling bars but after repositioning the antenna, they usually get all coupling bars.They were told not to use the belt for the insr (recharger).The patient turned the dial and repositioned the antenna several times since yesterday and cannot get the black boxes.Troubleshooting was done over the phone.They turned the dial through all four positions and attempted al.This did not resolve the issue.They did the al feature 3 times and the bars were not shaded.The insr antenna away from the implant and the numbers on the insr screen were above line was 56, left side 54 and right was 56.The insr antenna over the implant screen showed above implant 54-56, left at 54 and right at 56.The insr showed incompatible message.Ins was on, however, troubleshooting still did not resolve the issue, as there was a poor coupling screen.It was also reported the ins was tilted.No patient symptoms or further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 37791, product type: recharger.Product id: neu_unknown, product type: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the revision was scheduled for (b)(6) 2019.The rep would follow up with more information once the revision was complete.There were no further complications reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id 37791, serial# unknown, product type: recharger.Product id: neu_unknown, serial# unknown, product type: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer, via a manufacturing representative (rep), indicated they had trouble recharging and only got 6-8 bars when pushing the insr antenna down firmer.The rep met with the patient (b)(6) 2019 and could only get 2 coupling bars, at best.The implant had to be pushed up to get closer to the skin surface, and the rep thinks the anchor might have broken.The healthcare provider (hcp) anchored the implant since the previous implant had a pocket adaptor, which created a bigger pocket.It was noted the hcp was planning to revise the implant on (b)(6) 2019 undeliverable: no additional information was received.

Manufacturer Narrative

Section 'device' information references the main component of the system and other applicable components are: product id: neu_unknown, serial# unknown, product type: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the surgery went well.There were no visible signs of the battery flipping in the pocket, but the pocket was substantial, and flipping was suspected.The pocket size was revised, and the ing was secured with 2 sutures.Recharging efficiency was tested, and all 8 bars were accomplished.The patient was happy with the outcome.There were no further complications reported.

Manufacturer Narrative

Correction as previous supplemental report had incorrect aware date.Correct aware date is 08/21/2019.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

D2: please note that this device was used in an off-label manner as it was implanted for dystonia.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.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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8789742
• MDR Text Key: 151006911
• Report Number: 3004209178-2019-13490
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• 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,Followup
• Report Date: 11/10/2020

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: 03/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/05/2019; 08/08/2019; 09/21/2019; 09/21/2019; 11/10/2020
• Supplement Dates FDA Received: 08/08/2019; 08/21/2019; 09/04/2019; 09/04/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR