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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pocket Erosion (2013)

Event Type  Injury  

Event Description

It was reported that the patient¿s implantable neurostimulator (ins) was protruding through the skin and the pocket needed to be revised.The reporter stated that had not yet been any diagnostic testing or troubleshooting performed, but there would be in the future.It was noted that the ins was still implanted and remained in service.The patient status was noted to be alive without injury.Additional information received reported that the patient's pocket was revised on (b)(6) 2014.It was noted that the impedances were obtained before and after the surgery and all of the values were "normal." it was further noted that the cause of the protrusion was not determined.It was noted that the pocket appeared "normal" and there was no evidence that anything was wrong with the exception of the patient's complaints.The patient outcome was not provided.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3387s-40, lot# va0ak26, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va08uvg, implanted: (b)(6) 2013, product type: lead.(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: 3602103
• MDR Text Key: 4156393
• Report Number: 3004209178-2014-01440
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Date Device Manufactured: 11/28/2012
• 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