MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7426

Device Problems Break (1069); Migration or Expulsion of Device (1395); Low impedance (2285)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that during an implantable neurostimulator (ins) replacement surgery, the healthcare professional (hcp) noticed there was damage to the left extension.There was a severed connection in the area near the ins and the ins was twisted in the pocket.The right ins was replaced since the ins was at end of service (eos).The left ins was not replaced because, the patient was not consented for an extension replacement.The patient was not having any therapy issues related to the left ins.Prior to surgery, the manufacturing representative did not do telemetry with the ins.After they surgery, the left ins was interrogated and a short was noticed on electrodes 0 and 3.Impedances of less than 50 ohms were measured on 0-3.The cause of the event was not determined.The left ins was turned off until the revision and the patient was experiencing symptoms on their right side.Another revision was planned on the left side to replace the extension and ins.

Manufacturer Narrative

Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0313908v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0313844v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension.(b)(4).

• Brand Name: SOLETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4868358
• MDR Text Key: 15907562
• Report Number: 3004209178-2015-12221
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2015
• Date Device Manufactured: 01/28/2010
• 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): Required Intervention
• Patient Age: 00067 YR