MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient experienced overstimulation and shocking and jolting sensations.It was also noted that the patient had ¿electrical sensations¿ at the implantable neurostimulator (ins) pocket site related to ¿optical sensations.¿ impedance testing was performed and found low impedances of 59 ohms.The cause of the issue was not known and the issue was not resolved.The patient status at the time of report was unknown.Additional follow up is being performed to obtain the patient outcome.A supplemental report will be submitted if additional information is received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received which reported that surgery was required as a result of the impedance issues previously reported.Initially, the implantable neurostimulator (ins) was tested and low impedances, all between 50 ohms and 70 ohms, were measured on 3 poles on the right electrode.The low impedances persisted when testing was performed on the adaptor.After changing the adaptor, the impedances of those poles were between 819 ohms and 831 ohms.The ins was then connected, and the same low impedances were observed on the ¿first canal¿ (0-7).The canal was changed to 8-15, and a low impedance of 56 ohms was measured on poles 12 and 15.After opening the ¿safety cap¿ while checking the connection between the lead and extension, it was discovered that there was damage to the wire coating on both leads, above the connection point of the extension and lead.That portion of the leads had no wire coating.Additionally, the wire coating "on the middle of one lead" was damaged my mechanical removal.This was determined to have been the cause of the impedance issue.An ¿emergency¿ replacement of the patient¿s extensions and leads were required on that same day due to the ¿extreme dystonia problems¿ of the patient without stimulation.The new leads/extensions were then connected to the patient¿s ins.Impedances were subsequently ok and the issue resolved.X-rays were also taken, but the results were not provided.After the procedure, therapy was switched on and the patient ¿felt good¿ in the operating room.It was noted that the patient had been placed in the intensive care unit for monitoring.

Manufacturer Narrative

Concomitant products: product id 3387-40, serial # unknown, explanted: (b)(6) 2014, product type lead; product id 3387-40, serial # unknown, explanted: (b)(6) 2014, product type lead; product id 7482, # serial # unknown, explanted: (b)(6) 2014, product type extension; product id 7482, serial # unknown, explanted: (b)(6) 2014, product type extension; product id 64002, serial # unknown, implanted: (b)(6) 2011, product type adapter.(b)(4).

Manufacturer Narrative

Analysis of lead model 3387-40 sn: unknown found the #0 and #1 conductors were broken 9.5 cm from the distal end due to overstress damage.All connector sleeves were stretched and all conductors were broken at the connector weld sites.Breached metal-induced oxide (mio) was observed on the outer insulation at the proximal end of the lead.Analysis of lead model 3387-40 sn: unknown found no significant anomalies.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• 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: 4200592
• MDR Text Key: 4984693
• Report Number: 3004209178-2014-20375
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2014

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: 10/28/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 10/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2014; 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2010
• 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): Life Threatening; Required Intervention