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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that there was a lead/extension issue, high impedance values were detected after the implantable neurostimulator (ins) was replaced.Impedance values were normal prior to ins replacement.The patient had a loss of stimulation/therapeutic effect that was sudden and the patient had a shocking/jolting sensation.Action required was explant and replacement of the extensions.Diagnostic testing/troubleshooting had included impedance testing, x-rays and reprogramming.The issue was resolved but the cause of the issue was not determined.The extension was malfunctioning.There was a less than 50% therapy relief at the lead extension connection location and extension location.Since the extension revision the patient was doing fine with the deep brain stimulator therapy.The patient was back to original settings, impedances were normal and symptom control was optimized.

Manufacturer Narrative

Concomitant products: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension.Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead.Product id: 3387s-40, lot# v867085, implanted: (b)(6) 2012, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Concomitant medical products: product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension.Product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension.Product id 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead.Product id 3387s-40, lot# v867085, implanted: (b)(6) 2012, product type: lead.Product id 37642, serial# (b)(4), product type: programmer, patient.Analysis of the extension indicated that there was no significant anomaly, the extension body was cut through, the product was segmented.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4734183
• MDR Text Key: 5702987
• Report Number: 3004209178-2015-08037
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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: 00080 YR