MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2352-70

Device Problems Difficult to Remove (1528); Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: model number/catalog number: sc-2352-70; serial number: (b)(4); batch/lot number: 21086018; model/catalog description: linear 3-4 lead 70 cm.The explanted devices were not returned to bsn as they were discarded by the medical facility.

Event Description

A report was received that the patient was experiencing loss of stimulation due to leads were implanted in occipital mucosa.The patient underwent a lead revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Event Description

A report was received that the patient was experiencing loss of stimulation due to leads were implanted in occipital mucosa.The patient underwent a lead revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2352-70 sn: (b)(6).Device evaluation indicated that the complaint of the lead being stuck in the ipg port has been confirmed.The clean cut portion of the lead was stuck in the ipg port.The lead was removed, and visual inspection of the proximal array revealed that contact number 6 was deformed.It appeared that it was crushed by the ipg setscrew at one point.This damage suggests that the lead was not fully inserted into the ipg port when the set screw was tightened.The deformed/crushed contact number 6 resulted in the inability to remove the proximal array from the ipg port.The probable cause selected for the crushed contact is unintended use error caused or contributed to event.The complaint regarding the patient losing coverage couldnt be fully investigated due to damage done to the lead during the explant procedure and the incomplete product return.No other anomalies were identified on the returned portion of the lead aside from the crushed contact number 6.The probable cause for the allegation of the patient losing coverage is cause not established.The clean-cut damage to the lead body is a result of a typical explant procedure and it is not considered a failure.

• Brand Name: LINEAR 3-4
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9851302
• MDR Text Key: 184045599
• Report Number: 3006630150-2020-01284
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: 08714729789581
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

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: 09/08/2019
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 21086018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR