MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG REOCOR D; EXTERNAL PACEMAKER

Model Number	365529
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
We received a voluntary medwatch report from the fda.The report was sent in from (b)(6) health ((b)(4)).The report is: when a (b)(6) year old male was at a critical time in the surgery the external pacemaker and cable failed to properly function.The patient's heart quickly distended and a hole was emergently made in the heart to decompress the heart in order to save the patient.Once a proper functioning cable and box were retrieved (2 boxes later), the hole that was emergently made needed to be fixed.(b)(6) health cannot provide the serial numbers of the external pacemakers that were used.(b)(6) health claimed that the devices were sent to their biomed group where they tested fine and were not returned to biotronik.
Additional Manufacturer Narrative
Because serial numbers are unknown, we do not have a manufacture date.The re-inspection of the returned devices revealed severe damages caused by strong external forces, i.E.Drop damages, in all cases.Three devices showed signs of manual opening of the housing and attempts to self-repair were visible.Additionally, all returned devices had penetration of fluid (e.G.Water) into the device housing, which led to corrosion and extensive damage to the internal circuit board.In summary, all devices had been returned with severe damages.No specific failure mode was identified and there was no material or manufacturing issue related to the returned devices.

• Brand Name: REOCOR D
• Common Device Name: EXTERNAL PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7962354
• Report Number: 1028232-2018-03492
• Device Sequence Number: 11197248
• Product Code: OVJ
• UDI-Device Identifier: 04035479110055
• UDI-Public: 04035479110055
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 365529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization