MAUDE Adverse Event Report: OSYPKA MEDICAL GMBH ST. JUDE MEDICAL MODEL 3085; EXTERNAL PULSE GENERATOR

Model Number 3085

Device Problems Loose or Intermittent Connection (1371); Deformation Due to Compressive Stress (2889)

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

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been provided for investigation.It could be confirmed that the used 9v (b)(6) battery has not contacted well to the pacemaker battery terminals springs.The battery terminal springs were permanently bended.Additionally the following damages were found on this device: ctrl-out connector was bended and ctrl-out protection cap damaged, battery compartment lid damaged - latch and release button cracked, atrium-sense knob missing.These damages were probably caused by mechanical impact or drop down.9v batteries (6lr61, 6f22) can have a range of total length between 46.5mm and 48.5mm according to iec 60086-2.The used 9v (b)(6) battery is 46.6mm long and on the lower limit.The battery compartment of the model 3085 is designed to fit all possible 9v batteries and protect for permanent terminal spring bending in normal use and slightly rough handling.But parts can be damaged permanently or brake when the device drops to the floor or in case of inappropriate handling.Osypka medical have been in direct contact to the reporter of the incident.The hospital is using 33 units of the sjm model 3085 and 10 units of the osypka pace 203h which is technical identical to the 3085.The reporter was afraid that other devices in use could have been affected as well and asked for a procedure (and received it) how to investigate this.The hospital returned one more device with s/n (b)(4) which also had permanent bended terminal springs and other mechanical damages.So, 2 devices out of 43 were found with contact problems when using the small (b)(6) battery.

Event Description

External pacing box attached to patient post cardiac surgery.No underlying rhythm.Box shows full battery power, until it is moved when it alarms 'low battery'.As patient dependent on pacing box was changed to alternative which left patient with no cardiac output for a matter of seconds while box was changed.Additional information given in shipping documents from abbott/st.Jude medical together with the device sent for evaluation and repair date 2019-03-20: "external pacemaker cut out.Customer thinks that because different length batteries have been used, when a shorter one is selected this has led to a poor connection and so power was lost.Patient information (e.G.Age, weight, gender, etnicity, race, patients initials) cannot be handled by abbott due to personal data protection national legislation.".

• Brand Name: ST. JUDE MEDICAL MODEL 3085
• Type of Device: EXTERNAL PULSE GENERATOR
• Manufacturer (Section D): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• Manufacturer (Section G): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• Manufacturer Contact: thilo thuemecke ; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• MDR Report Key: 8498855
• MDR Text Key: 151939661
• Report Number: 9681449-2019-00001
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3085
• Device Catalogue Number: 2085868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other