MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LINOX SD 65/16; ICD LEAD

Model Number 350053

Device Problems Premature Elective Replacement Indicator (1483); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

Till today, the lead has not been provided for analysis and could therefore not examined itself.The returned icd first underwent a status interrogation.The interrogation with a clinical programmer showed the device status eos and 268 registered charge processes.The memory content of the icd was checked.The check of the available iegms showed interference signals in the ventricular channel, which led to several shock deliveries, matching the clinical observation.The signal sensing of the device was then checked, which proved to be free of noise.The icd sensed supplied signals free of interference.The continued analysis of the shock holter entries showed that the icd performed at least 128 charge processes on (b)(6) 2017, within 2 hours.These rapidly consecutive charge processes led to the eos activation.The eos state was removed with a technical programmer, and a subsequent interrogation of the icd showed the battery state eri.In a next step, the icds capability to provide therapy was tested.The antibradycardic output signal was normal and matched the programmed values.A fibrillation signal was supplied, and the device reacted according to specifications with a defibrillation shock.The specified energy level was reached, and the charge time proved to be unremarkable.No indications of a device malfunction were found during the analysis.In summary, the lead was not returned for analysis.The icd underwent a thorough analysis.The analysis showed that the device had activated the battery state eos on (b)(6) 2017.The eos activation occurred due to numerous, rapidly consecutive charge processes, caused by interference signals in the ventricular channel.The icd proved to be fully functional during an extensive examination.If the lead itself should become available, the incident will then be updated accordingly.

Event Description

Ous mdr - it was reported that the patient received multiple inappropriate shocks.The icd was replaced due to battery depletion.The rv lead was capped and a new lead was implanted.No additional adverse patient events were reported.Should additional information become available this file will be updated.

• Brand Name: LINOX SD 65/16
• Type of Device: ICD LEAD
• 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: 6504407
• MDR Text Key: 73186921
• Report Number: 1028232-2017-01168
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 350053
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2008
• 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): Hospitalization