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

Model Number 37601

Device Problems High impedance (1291); Low impedance (2285)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

See manufacturer's report #3004209178-2019-11919 for information regarding the previous main device of the system.This report is for the new implantable neurostimulator (ins) which was implanted during the replacement surgery.Concomitant medical products: product id: 3387-40, lot# va17zer, implanted: (b)(6) 2018, product type: lead; product id: 3387-40, lot# va17zer, implanted: (b)(6) 2018, product type: lead; product id: 3708760, serial# (b)(4), implanted: (b)(6) 2019, product type: extension; product id: 3708760, serial# (b)(4), implanted: (b)(6) 2019, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia.It was reported the patient's dystonia symptoms got worse.It was reported there was a low impedance on the right lead contact one which changed from 711 ohms to 600 ohms when pressure was applied to the extension at the level of the head behind the ear.No external factors were reported to be related to the event.It was reported there would be an operation on (b)(6) 2019 to resolve the event.There was a high impedance on contact 8 of the left lead of 2456 ohms, but all other impedances were in range.The patient was programmed on contacts 9 on the left side and 1 on the right side.Intra-operative impedances were measured on the right lead, right lead plus extension, and again on only the right lead, but all impedances were in range.Intra-operative impedances of the left side system revealed high impedances on all combinations involving contact 8.Both extensions were replaced, but there was no change in the impedance.The ins was changed without change in the impedance.Finally the new right extension was replaced, but there was no change in impedance.Impedance measurement noted impedance on c/1 and c/3 of 582 and 557 ohms, respectively.The patient status was okay and stimulation was okay.No further complications were reported.Refer to manufacturer report #3004209178-2019-11919 for details pertaining to the previous main device of the system.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.High impedance was not resolved with ins and extension replacement.The cause of the low and high impedances was not determined.The patient's symptoms had improved since the intervention, and no additional actions had been taken and none were planned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.The patient was okay and in the hospital.The therapy impedance was ok: right: 1195 ohms 3.0ma and left 940 ohms and 3.8ma.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information clarified the patient was in the hospital (referenced in last supplemental) for a follow-up appointment.

Manufacturer Narrative

H3: the returned extension (model: 3708760, serial: (b)(4).Was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.H6: method code 10 applies to the returned extension (b)(4); 4117 applies to the implantable neurostimulator (ins).Result code 213 applies to the extension; 3221 applies to the 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.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
• 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: 8713393
• MDR Text Key: 148464990
• Report Number: 3004209178-2019-11921
• Device Sequence Number: 1
• Product Code: MRU
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/23/2019

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 Date: 08/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 07/09/2019; 07/16/2019; 09/23/2019
• Supplement Dates FDA Received: 07/02/2019; 07/15/2019; 07/25/2019; 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1