MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-8336-70

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Paralysis (1997)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: sc-1160, serial number: (b)(4), batch/lot number: 339185, model/catalog description: spectra wavewriter ipg kit.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.  a review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.The location of the explanted devices are not known.

Event Description

A report was received that the patient underwent an explant procedure due to epidural abscess.The physician believed that the abscess was due to excessive bleeding.It was unknown if cultures were taken.The patient also had a loss of function in lower extremities which was not believed to be device related but per the physician was related to the excessive bleeding.

• Brand Name: COVEREDGE 32
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8092628
• MDR Text Key: 128012158
• Report Number: 3006630150-2018-61903
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: 08714729832676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2020
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7029812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• 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): Required Intervention
• Patient Age: 66 YR