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

Model Number 37601

Device Problem Break (1069)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that there was a loss of therapeutic effect, the patient¿s left hand had begun to shake and they had found a wire was broken.It was unknown when it had broken but the shaking had begun in (b)(6) of 2010.The patient had put up with it and had said it had not bothered him.The patient¿s hand would turn in and he would keep it closed.The lead and implantable neurostimulator (ins) were replaced and the issue was resolved.The patient had it adjusted and then had never had to go back again.

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot# v003141, implanted: (b)(6) 2006, product type: lead.Product id: 3387-40, lot# v001355, implanted: (b)(6) 2006, product type: lead.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type: extension.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2013, product type: extension.(b)(4).

• Brand Name: ACTIVA
• 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: 4333043
• MDR Text Key: 5139732
• Report Number: 3004209178-2014-24002
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2011
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2014
• Date Device Manufactured: 09/25/2009
• 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: 00073 YR