MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem High impedance (1291)

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

Event Date 05/13/2015

Event Type  Injury  

Event Description

It was reported that during a stage two implant procedure to place two extensions and an implantable neurostimulator (ins), high impedances of greater than 40,000 ohms was measured.All electrode pairs on the left side with electrode one had high impedances when tested at 3v.Troubleshooting involved disconnecting and reconnecting the extension and ins, but the impedance issue remained.The extension and lead were then disconnected and reconnected, but the issue remained.Impedances were then tested directly on the lead and they were normal.The left extension was then explanted and replaced.Impedances were measured to be within normal range after the extension was replaced and the issue was resolved.The manufacturing representative and healthcare professional (hcp) were unable to visualize any damage to the extension.

Manufacturer Narrative

Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension.(b)(4).

Manufacturer Narrative

Analysis of the extension found no anomalies.

Manufacturer Narrative

Concomitant: product id 3708660, serial# (b)(4), implanted: 2015-(b)(6), explanted: 2015-(b)(6), product type extension.Analysis results were not available at the time of this report.A follow up report will be sent when analysis is completed.

Event Description

Additional information received reported that the device was not used with/in patient.The intended use of the device was for treatment.There was no patient death and no patient injury.The patient had recovered without sequelae.

Manufacturer Narrative

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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 4802630
• MDR Text Key: 5924223
• Report Number: 3007566237-2015-01462
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 00070 YR