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

Model Number 37604

Device Problems High impedance (1291); Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Activa pc+s model 37604 is not a marketed device, but is similar to marketed devices.Therefore, while a surgical intervention occurred, the event is reportable for malfunction, not for serious injury.Concomitant medical products: product id: 3708760, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: extension.Product id: 3708760, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: extension.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.Product id: 3708760, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: extension.Other relevant device(s) are: product id: 3708760, serial/lot #: (b)(4), ubd: 16-jun-2021, udi#: (b)(4).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.

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

The ins and extensions: (b)(4) were returned.Product id: 3708760, serial# (b)(4),implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: extension.Product id: 3708760, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: extension.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, explanted: (b)(6) 2019, product type: extension.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.Extension, serial#: (b)(4) was mistakenly reported to medtronic.The correct serial number is (b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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

The returned implantable neurostimulator (ins) was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The ins passed functional testing.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.Analysis identified that the insulation on the extension was cut; however, electrical testing determined that continuity was complete and there were no electrical shorts between the circuits.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.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.Analysis identified that the insulation on the extension was cut; however, electrical testing determined that continuity was complete and there were no electrical shorts between the circuits.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA PC + S
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8713343
• MDR Text Key: 149782901
• Report Number: 3004209178-2019-11919
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 37604
• Device Catalogue Number: 37604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 07/09/2019; 09/23/2019
• Supplement Dates FDA Received: 07/02/2019; 07/15/2019; 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention