MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3387

Device Problems Bent (1059); Shipping Damage or Problem (1570)

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

Event Date 09/05/2014

Event Type  malfunction  

Event Description

It was reported that during a unilateral lead placement on the date of this report, it was noticed that the distal tip below electrode 0 was bent.The surgeon had not wanted to implant the lead so a second lead was opened from the same lot and the second lead had the same problem.Visual inspection indicated that contact 0 looked normal but the distal rubber portion under the 0 contact looked bent.Both leads would be returned.A lead connection check was not performed.No mishandling had been observed during removal of the leads from the packaging.It was determined that the lead had been bent in the packaging.The leads were not implanted and there was no patient involvement.A lead with a different lot was used.There was no patient injury or patient death.Reference manufacturer¿s report number: 6000153-2014-00170.

Manufacturer Narrative

Concomitant medical products: product id neu_stylet_acc, serial# unknown, product type: accessory; product id neu_stylet_acc, serial# unknown, product type: accessory; product id 3387, lot# va0kc0b, product type: lead.(b)(4).Analysis of the lead found the distal end of the lead bent, new out of box.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• 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: 4126115
• MDR Text Key: 4938084
• Report Number: 6000153-2014-00171
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2017
• Device Model Number: 3387
• Device Catalogue Number: 3387
• Device Lot Number: VA0KC0B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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