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

Model Number 37612

Device Problems Bent (1059); Break (1069); Connection Problem (2900); Activation, Positioning or Separation Problem (2906); Impedance Problem (2950)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_tunneling tool, serial# unknown, product type: accessory.Product id neu_unknown_lead, serial# unknown, implanted: 2018, product type: lead.Product id: neu_unknown_ext, serial# unknown, implanted: (b)(6) 2018, product type: extension.Both unknown extensions and unknown leads are fdc (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported during the procedure there was difficulty connecting the lead into the extension.It was reported the patient had a unilateral system and they explanted the old lead and placed 2 new leads in late (b)(6) 2018 to create a bilateral system.On the day of the call they were going to do a stage 2 procedure and remove the old ins and extensions from the unilateral system.When they tried to explant the old extension, they disturbed the tissue so that when they were tunneling to pass the two extensions, the tunneler broke and they had difficulty tunneling the extensions.They ultimately did get the extensions tunneled.One lead connected fine to the new extension but on the other side they had difficulty connecting and could not fully insert the lead into the extension.The caller was unsure which side they had difficulty with as the marker to designate sides was lost during tunneling.When they tried to disconnect the lead from the extension, they were not able to pull the lead out.The hcp tried taking out the setscrews but this did not resolve.They were able to get normal impedances on the middle contacts (1 and 2 on the lead) with impedances of about 900 and 1100 ohms but pairs with the other contacts were out of range.The hcp decided to leave the lead partially inserted into the extension in hopes that the electrodes with normal impedances would provide therapy.No product damage was caused or discovered during the surgery.No symptoms were reported.No complications were reported or anticipated.

Manufacturer Narrative

Continuation product id neu_tunnelingtool lot# serial# unknown implanted: explanted: product type accessory product id 3387s-40 lot# va1ks06 serial# implanted: 2018 (b)(6)explanted: product type lead product id 3708660 lot# serial# (b)(4) implanted: 2018 (b)(6) explanted: product type extension product id 3708660 lot# serial# (b)(4) implanted: 2018 (b)(6) explanted: product type extension product id 3387s-40 lot# va1ks06 serial# implanted: 2018 (b)(6) explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the tunneler broke after numerous tries of pulling the extensions.It got caught in the tissue.It was also believed the lead was bent and the damaged lead caused the out of range impedances.It was reported the lead would be replaced.

Manufacturer Narrative

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

Event Description

Additional information was received stating no lead replacement was scheduled because it was unsure if it was needed.The contacts placed properly in the extension may have been ok.The leads were not found to be bent out of box; attempting to place the leads in the extension may have caused the damage.

• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7266650
• MDR Text Key: 100001456
• Report Number: 3007566237-2018-00446
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

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: 10/14/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/13/2018; 03/06/2018
• Supplement Dates FDA Received: 02/20/2018; 03/08/2018
• Date Device Manufactured: 11/16/2017
• 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
• Patient Age: 54 YR