MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3387S-40

Device Problems Bent (1059); High impedance (1291); Difficult to Insert (1316); Difficult to Remove (1528)

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

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3550-29, product type: accessory.(b)(4).

Event Description

The company representative (rep) reported that after lead placement on both sides of gpi, the implantable neurostimulator (ins) was placed in both breasts after putting the adapters in the right side and connecting them to both breasts.Impedance was measured.Right side there was no impedance abnormalities.Left side only c, 0 were 2,242ohms and high impedance was displayed.The ins was reconnected in the left side with the lead, reconnected the adapter and the lead.When reconnecting , the adapter connection and the electrode region on the adapter side of the lead did not overlap neatly.It was fixated forcefully using a torque wrench while it was pushed down.Impedance was measured again, but it was still around 2,000ohms and high impedance was displayed.Due to the conditions the physician tried to pull out the left lead after loosening the screws, but could not.The connector between the lead and adaptor was unstable.Even after all the connection screws were removed with a torque wrench, could not remove the left lead.The physician decided that pulling the lead out forcefully may cause the lead to disconnect, so the connection region of the adapter was taken apart with a scalpel so as not to damage the lead.When the lead was removed, the tip was a little curved/bent.A new adapter was unwrapped and then was tried to reconnect the lead and the adapter.The metal in the connection region turned, became slanted, due to the torque wrench.The bond between the metallic region and silicone was loose.Released the connection between the lead and adapter.The adapter could not be fixated to the lead very tightly.The external neurostimulator (ens) and a twist lock cable was used to measure impedance in order to check whether or not the lead was disconnected, but measurements could not be taken because the stylet could not be inserted, perhaps because the tip was slight curved.In the end, the stylet was stuck into the lead from the inside.The physician decided to place the lead again, she conducted a re-operation after explaining the situation to the patient's family.The lead was removed, and a new lead and adapter were placed.The lead had ruptured.There was no problem with the implantable neurostimulator (ins), so the ins originally opened was used.Impedance was measured after placement was complete, there were no abnormalities.The re-placement procedure was conducted by splitting up and placing the left and right adapters, after giving up on the idea to put both adapters together.A 40cm adapter was used in this situation, there were problems with the 60cm adapters.The devices were noted to be defective, had an anomaly, and a malfunction occurred.The physician wanted some kind of improvement strategy, such as something that could fixate the adapter screw when tightening.The indication for use included dystonia.If additional information is received, a follow up report will be sent.Reference manufacturer report# 2649622-2016-00120 and 2649622-2016-00121.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 37602, product type: implantable neurostimulator.

Event Description

The following information has already been reported in manufacturer report #3007566237-2016-01847: the health care provider (hcp) additionally reported via the company representative (rep) that lead side became damaged during the operation on (b)(6) 2016.No symptoms were reported.The indication for use included parkinson's disease.Any additional information regarding this event will be reported in this manufacturer report.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5396378
• MDR Text Key: 37002539
• Report Number: 6000153-2016-00254
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2018
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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