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

Model Number SC-2218-70

Device Problem High impedance (1291)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: sc-2218-70, serial number: (b)(4), batch/lot number: 14914930, model/catalog description: linear st lead kit 70 cm.Model number/catalog number: sc-1110-02, serial number: (b)(4), batch/lot number: 15017355, model/catalog description: precision ipg kit.

Event Description

A report was received that the patient was experiencing severe pain near the mid thoracic area at the right of the spine.The patient was admitted to the hospital and was diagnosed with having a lipoma.Impedances were checked and found that there were high impedances on patients leads.The physician could not determine what was causing the patients new pain area.It was also noted that the patient had a history of cancer.The patient will undergo an explant procedure.

• Brand Name: LINEAR ST
• 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: 8348136
• MDR Text Key: 136468485
• Report Number: 3006630150-2019-00619
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• UDI-Public: 08714729767749
• 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: 02/18/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2014
• Device Model Number: SC-2218-70
• Device Catalogue Number: SC-2218-70
• Device Lot Number: 14970638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2012
• 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; Required Intervention
• Patient Age: 56 YR