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

Model Number SC-1132

Device Problems Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Unspecified Infection (1930); Paralysis (1997); Seizures (2063); Sepsis (2067); Coma (2417); No Code Available (3191)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Explant date: approximately (b)(6) 2017.

Event Description

A report was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support.During this time the patients heart stopped and a temporary pacemaker was implanted.The patient also reported that she developed methicillin-resistant (b)(6) , meningitis, and sepsis.The patient underwent an explant procedure and received iv vancomycin for six months for infection.In addition, she stated she was bed ridden and spent six months in a nursing home.Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping.Patient also has hearing and memory loss.

Manufacturer Narrative

(b)(6).Additional information received: physician does not think that the infection was device related as the patient was septic.All devices have been explanted and nothing will be returned.He further states that the implanted device was not helping with her pain.Additional suspect medical device components involved in the event: model: sc-4316, serial/lot: (b)(4), description: clik anchor.Model: sc-8216-70, serial/lot: (b)(4), description: artisan lead 70cm.As the device involved in the complaint has not been returned, the complaint investigation site (cis) could not perform a device analysis.However, a review of the complaint report, device history record, and sterilization record were found to be satisfactory and did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.Explant date: approximately (b)(6) 2017.

Event Description

A report was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support.During this time the patients heart stopped and a temporary pacemaker was implanted.The patient also reported that she developed (b)(6), meningitis, and sepsis.The patient underwent an explant procedure and received iv vancomycin for six months for infection.In addition, she stated she was bed ridden and spent six months in a nursing home.Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping.Patient also has hearing and memory loss.

Event Description

It was reported was received that the patient claims that approximately four years after being implanted she was hospitalized and in a coma for 55 days, and had four blood transfusions while on life support.During this time the patients heart stopped and a temporary pacemaker was implanted.The patient also reported that she developed methicillin-resistant staphylococcus aureus, meningitis, and sepsis.The patient underwent an explant procedure and received iv vancomycin for six months for infection.In addition, she stated she was bed ridden and spent six months in a nursing home.Due to the scar tissue that resulted from the infection, the patient now has lost that ability to move and has difficulty walking and sleeping.Patient also has hearing and memory loss.Additional information was received that the physician does not think that the infection was device related as the patient was septic.All devices have been explanted and nothing will be returned.He further states that the implanted device was not helping with her pain.Additional information was received from the patient that the devices would overheat inside her back and buttocks.She further stated that the infection also affected her neck, shoulder, back, wrists, and gall bladder.Patient had to have breast reduction surgery and shoulder reversal implant.She additionally stated that she had the stimulator removed and died on the operating table, and suffered from a stroke and seizures.

• Brand Name: PRECISION SPECTRA
• 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: 7886947
• MDR Text Key: 120643944
• Report Number: 3006630150-2018-60936
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2015
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 16493193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 58 YR