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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

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MPRI ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) Back to Search Results
Model Number 3387S-40
Device Problem Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional (hcp) by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for the treatment of dystonia.During stage, i procedure the surgeon placed the lead for the right side.An impedance test was run that showed a low impedance on contact combination 0/1.The surgeon loosened the lead stop holding the lead in place and ran another impedance test that showed the same low.The surgeon resecured the twist-lock cable adapter and the impedance test showed the same low.It was reported the surgical manipulation could have caused the issue.The lead stop may have been over tightened.The surgeon did not feel that it was tightened too much.Several impedance tests were run.The rep grabbed a different lead, and the surgeon used the new lead and there were no impedance issues.During the stage ii procedure, the surgeon tunneled and placed the extensions.The extensions were connected to the leads and plugged into the battery.An impedance test was run and found a high on all combinations of contact 9.The surgeon reconnected the extension into the battery and the lead into the extension.It did not appear that there was excessive force used when p lacing or connecting the extension.The same high came back again.A twist-lock cable was used to test the lead, there was not an impedance issue on the lead.A new extension was placed and connected to the battery and lead.The final impedance test showed normal impedance values.No symptoms or complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the lead (3387s-40) revealed the #0 and #1 conductors cross over under the #0 connector sleeve causing a short between the conductors.Analysis of the extension ((b)(4)) revealed no anomaly.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.
 
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Brand Name
ACTIVA
Type of Device
IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8444197
MDR Text Key139573454
Report Number2649622-2019-04817
Device Sequence Number1
Product Code MRU
UDI-Device Identifier00643169752290
UDI-Public00643169752290
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/11/2021
Device Model Number3387S-40
Device Catalogue Number3387S-40
Device Lot NumberVA1W3VG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2019
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received03/22/2019
Supplement Dates Manufacturer Received05/03/2019
05/08/2019
11/05/2020
Supplement Dates FDA Received05/08/2019
05/16/2019
11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Age10 YR
Patient Weight46
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