MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG STYLET S 65-C

Model Number 395098

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt, the stylets (one of the type s 65 c and two s 65 k) were subject to an extensive analysis.The visual inspection revealed that the s 65 k stylets were within specification.However, it can be confirmed that the s 65 c stylet which is packaged as a spare styletin a stylet ring together with the s 65 k versions in the sterile blister deviate from specification lengthwise.Subsequent analysis showed that the s 65 c stylet is too short by 4 cm confirming the physician's observation.At a next step, the quality documents associated with the manufacturing process of this lead were re-investigated.The stylets are produced and packaged by a supplier.The supplier's root cause analysis identified that an individual mistake of a production work er resulted in the shipment of stylets of wrong length.Corrective measures have been taken to prevent a recurrence of this issue.We do apologize for this occurrence and for the inconvenience you may have encountered.

Event Description

Physician stated the medium stylet is shorter than the others.There were no adverse patient events reported.Should additional information be received, this file will be updated.

• Brand Name: STYLET S 65-C
• Type of Device: STYLET
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 5913784
• MDR Text Key: 53488719
• Report Number: 1028232-2016-03003
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 395098
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• 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