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

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

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

Event Type  Injury  

Event Description

It was reported that a post-operative ct scan showed that the left lead moved superior by a few centimeters.The stimlock was reported to be the issue; not the lead.The original lead that was implanted was removed and a new lead was implanted in the left hemisphere at the original implant location.Once the lead was replaced the implantable neurostimulator (ins) was implanted in the left chest.The patient was alive with no injury.

Manufacturer Narrative

Product id 3389s-40, lot# va0rr28, implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4); product type extension product id 3389s-40, lot# va0rr28; product type lead.(b)(4).

Manufacturer Narrative

Product id neu_stimloc_acc; product type accessory product id neu_leadcap_acc; product type accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the lead, lot #va0rr28, found the proximal end stretched.There was no significant anomaly.Analysis of the unknown stimloc found no anomaly.The returned stimloc clip and cap were tested with a load of 0.5 pounds of force on a known good lead and the base and the lead did not move.(b)(4).

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: 4546652
• MDR Text Key: 5517636
• Report Number: 3004209178-2015-03657
• 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: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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