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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37612
Device Problems Inadequacy of Device Shape and/or Size (1583); Unstable (1667); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Scar Tissue (2060); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2019
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 essential tremor and movement disorders.It was reported there was poor coupling.They can connect with the ins but they were getting 0 coupling bars.The battery was flashing at 50%.Troubleshooting was performed.They tried repositioning the antenna over the ins.The caller reported seeing "thermometer screen".The patient has seen this before and put antenna down to cool before continuing use.The caller did not allege that it was warm/hot.Troubleshooting did not resolve the reported issue.They were still getting a poor coupling screen and 0 coupling bars.It was reported the ins was confirmed to be flipped over and the hcp was aware.The hcp was waiting to replace the ins when new product was available.No further complications were reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient indicating this ins is smaller than the other one, which led to it flipping.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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.
 
Event Description
Additional information was received from the patient on 2020-apr-08.It was reported the implantable neurostimulator recharger (insr) is not charging the implantable neurostimulator (ins).They clarified that they have zero coupling boxes shown on the insr and the ins just keeps flashing.They states it takes them 3-4 days to charge the ins fully.They were supposed to have surgery to clean the scar tissue that is around the ins.They have been having charging issues for at least the past 3-4 months.A replacement recharger antenna was sent.Additional information was received from a consumer via a manufacturer representative (rep) on 2020-apr-15.It was reported the patient got a replacement antenna from repair and can only get 4-6 bars.The antenna gets really hot.They tried to use the antenna locate (al) 64-74 and still only got 6 bars.The rep tried using their spare recharger and was able to get 8 bars shaded.They added that the healthcare provider (hcp) thought the patient's implantable neurostimulator (ins) was flipped per x-ray.Technical services reviewed that coupling bars does not present this high usually with a flipped battery.A replacement recharger was sent.Additional information was received from a manufacturer representative (rep) on 2020-apr-24.It was reported the surgery to clean the scar tissue that is around the ins was not scheduled due to covid and the replacement recharger resolved the coupling issue.It was also stated that the cause of the coupling issue was not determined and the surgeon wants to revise.Additional information was received from a manufacturer representative (rep) on 2020-apr-28 reporting the revision for the flipped ins has not yet been scheduled.
 
Event Description
Additional information was received from a consumer reporting that the replacement recharger antenna resolved the coupling and charging issue.Their physician believes the scar tissue that is around the ins may be part of the issue.With the new charger, it is not giving them as many issues.When the recharger deep brain stimulation (dbs) battery was put in, it created an opening in the pocket.Scar tissue has grown over it.They are still planning to have the surgery to clean the scar tissue but no date as of yet.They are planning august or september.
 
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.
 
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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 Key8786055
MDR Text Key150876271
Report Number3004209178-2019-13420
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169529762
UDI-Public00643169529762
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2017
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Date Manufacturer Received05/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight61
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