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 Unintended Movement (3026); Migration (4003)

Patient Problems Inadequate Pain Relief (2388); No Code Available (3191)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model number/catalog number: sc-2352-70, serial number: (b)(4) , batch/lot number : 21301624, model/catalog description: linear 3-4 lead 70 cm.

Event Description

A report was received that the patients leads had moved.It was also mentioned that the patient has unsatisfactory coverage on the arms and hands.The patient will undergo a revision procedure wherein the leads will be repositioned.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the leads were repositioned.No device malfunction was suspected.The patient was doing well postoperatively.

Event Description

A report was received that the patients leads had moved.It was also mentioned that the patient has unsatisfactory coverage on the arms and hands.The patient will undergo a revision procedure wherein the leads will be repositioned.

• 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
• 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: 7757391
• MDR Text Key: 116249761
• Report Number: 3006630150-2018-60511
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: 08714729789581
• 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,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/07/2019
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 20248015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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: 52 YR